Assessing Cravings Among Individuals with Alcohol Dependence Syndrome Prescribed with Anti-craving Medication: A Prospective Observational Study

Abstract

Background:

Alcohol Dependence Syndrome (ADS) is a prevalent condition marked by difficulty controlling alcohol use, with significant global health impacts. Despite the effectiveness of anti-craving medications like Naltrexone, Acamprosate, Baclofen, Ondansetron, and Topiramate, these medications remain underutilized by healthcare providers. This study aims to assess the relationship between craving and relapse rates among individuals prescribed anti-craving medications and to explore the correlation between medication dosage and craving severity.

Methods:

This was a prospective observational cohort study in which individuals prescribed anti-craving medications were monitored over three months. The study utilized the Penn Alcohol Craving Scale (PACS) to measure craving intensity and the Medication Adherence Rating Scale (MARS) to assess medication adherence. Alcohol use patterns were categorized into relapse, lapse, abstinence, and active use based on predefined operational definitions.

Results:

Participants were between 30 and 50 years old and predominantly male. Severe dependence was observed in the majority of cases, and baclofen was prescribed to most participants. Pearson’s correlation between Severity of Alcohol Dependence Questionnaire (SADQ-C) and PACS scores was r = 0.304 (p = .017), and MARS scores significantly predicted PACS scores (R = 0.757, R² = 0.573, p < .001). Most participants were in the action phase, with a significant proportion maintaining abstinence. However, relapse rates increased as the study progressed. Overall, adherence to anti-craving medications reduced cravings and facilitated abstinence.

Conclusions:

The research noted a significant reduction in craving in individuals receiving anti-craving medications. Nevertheless, no statistically significant correlation was identified between the dosage of Baclofen and PACS scores.

Keywords

Alcohol dependence syndrome craving anti-craving medication baclofen naltrexone

Key Messages

The integration of various anti-craving medications, including naltrexone, acamprosate, baclofen, and topiramate, represents a promising intervention in reducing craving and preventing relapse among individuals grappling with alcohol dependence.

Enhanced knowledge and utilization of anti-craving medications can lead to the development of more effective treatment protocols and policies, ultimately improving the overall management and outcomes for individuals with alcohol dependence.

Consistent adherence to anti-craving medications like baclofen and naltrexone has been shown to significantly reduce craving and provide crucial support for individuals striving to maintain abstinence from alcohol.

Alcohol Dependence Syndrome (ADS) is a condition marked by compulsive alcohol use, impaired control, tolerance, withdrawal, and continued use despite harmful consequences.^{1, 2} Based on data from the World Health Organization, alcohol abuse causes 3 million deaths per year, which makes up 5.3% of all deaths worldwide and 5.1% of all diseases and injuries.³ Individuals with ADS often experience co-occurring psychiatric conditions, such as other substance use disorders, major depression, bipolar disorders, specific phobias, and antisocial and borderline personality disorders.^{4, 5} Additionally, individuals with ADS commonly experience a range of somatic as well as psychosocial issues, including hepatic disease, pancreatitis, and different types of cancer, as well as accidental injuries, aggression, violence, and suicide, which are also prevalent among this population.^{6, 7} Effectively managing craving is a critical aspect of addressing alcohol dependence,⁸ as craving refers to a strong desire or urge to re-experience the effects of a previously consumed psychoactive substance.⁹ Craving significantly elevates the risk of relapse, complicating the treatment of alcohol dependence.¹⁰ The use of anti-craving medications, such as Naltrexone, Acamprosate, and others like Baclofen and Topiramate, has emerged as a promising intervention to help mitigate these cravings and reduce the likelihood of relapse in individuals with alcohol dependence.^11–14 The advantages of using anti-craving drugs outweigh the potential side effects or the repercussions of untreated ADS.¹⁵ Despite their efficacy in clinical trials, these medications are underused by healthcare professionals.^{15, 16} While previous studies have explored the effectiveness of anti-craving medications in curbing cravings, there remains a gap in understanding their real-world impact on craving intensity in individuals with ADS. This observational study aims to assess the severity of craving and relapse rates in individuals diagnosed with ADS who are prescribed anti-craving medication. By monitoring these individuals over a specific period, the study seeks to understand the effectiveness of anti-craving pharmacotherapy in reducing craving severity and its implications on treatment outcomes.

Methods

Study Design and Ethical Considerations

The Institutional Ethics Committee approved this prospective observational cohort study, and data collection was conducted between January 2024 and June 2024. Written informed consent was obtained from all subjects before their inclusion in the study. The study adheres to the STROBE guidelines for cohort studies, with the checklist provided as Supplementary Online Material. The sample size estimation was based on a study by Rozatkar et al. (2016), which reported a 0.15 prevalence of craving following four weeks of Baclofen treatment (20–40 mg/day).¹⁷ Considering a 5% significance level and an 8% absolute error margin, this study’s required sample size was 61 participants.

Participants and Assessment

Participants were selected based on specific inclusion and exclusion criteria. Eligible participants included individuals diagnosed with ADS based on ICD-10 criteria,¹⁸ aged between 21 and 70 years, in a stable condition as determined by clinical evaluation, and with family members available to confirm instances of relapse. The lower age limit of 21 years was based on the legal drinking age in India, ensuring the inclusion of only legally eligible alcohol users. The upper limit of 70 years was set to minimize confounding from age-related comorbidities. Exclusion criteria included unwillingness to provide consent, declining follow-up or withdrawing consent, addiction to substances other than nicotine, lack of prescription for anti-craving medication, and severe psychiatric or medical comorbidities that impeded interviews.

Tools

A semi-structured proforma was developed to gather socio-demographic and clinical details, including alcohol use history, consumption patterns, and motivational stage. The Severity of Alcohol Dependence Questionnaire (SADQ-C), a 20-item screening tool, was used to assess the severity of alcohol dependence by evaluating craving, relief drinking, emotional and physical withdrawal symptoms, and drinking frequency.^{19, 20} Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS), a five-item self-report tool assessing the frequency, duration, and intensity of craving, as well as the participant’s ability to resist drinking.²¹ Medication adherence was evaluated using the Medication Adherence Rating Scale (MARS), a 10-item self-report questionnaire designed to assess medication-taking behaviors, attitudes, and intentional and unintentional non-adherence.²² Motivation to change alcohol use behavior was assessed using the Transtheoretical Model of Motivation (TTM), which categorizes individuals into six stages: pre-contemplation, contemplation, preparation, action, maintenance, and termination.²³

Alcohol use patterns were categorized using a structured, clinically relevant classification system based on predefined operational definitions. Participants were grouped into five categories: abstinence (complete avoidance of alcohol),²⁴ relapses (return to previous drinking patterns following abstinence),²⁴ lapses (a single episode of use after a period of sobriety or reduced intake),²⁴ active use (ongoing consumption),^{18, 24} and abstinence in a protected environment (avoidance of alcohol within controlled settings such as hospitals, clinics, or under strict supervision).^{18, 24} These classifications were applied consistently during participant interviews and follow-up evaluations.

Study Procedure

Patients diagnosed with ADS who had undergone detoxification in the de-addiction ward were monitored through their medical records and anti-craving prescriptions. Participants were selected through consecutive sampling from the inpatient wards. Eligible individuals were informed about the study and invited to participate. Written informed consent was obtained, after which an investigator conducted a face-to-face interview using a semi-structured proforma to collect pertinent socio-demographic and clinical details. On Day 7 of detoxification, baseline assessments were performed, including the SADQ-C to assess the severity of alcohol dependence, the PACS to measure baseline craving, and TTM to determine the participant’s stage of motivation for behavior change.

Anti-craving medications were generally prescribed after one week of detoxification, and participants were monitored over three months. The MARS was applied one week after the initiation of anti-craving medication. Follow-up assessments were scheduled weekly during the first month and bi-weekly during the subsequent two months.

Follow-up Procedure

Participants were followed up for three months after the initiation of anti-craving medication. Follow-up assessments were scheduled weekly during the first month (Days 8, 16, 24, and 32) and biweekly during the subsequent two months (Days 48, 64, 80, and 96). A permissible variation of ±3 days was allowed to accommodate participant availability. Follow-up sessions were conducted through outpatient department (OPD) visits or structured telephonic interviews for those unable to attend in person. During each follow-up, participants were assessed for alcohol use status categorized as (abstinence, lapse, relapse, continued use or abstinence in a protected environment), craving levels using the PACS, medication adherence using the MARS, and their motivation status using TTM. The same structured questionnaire was used in both in-person and telephonic formats. For telephonic assessments, the investigator attempted to contact up to three times within the scheduled window, and responses were systematically recorded in the case records.

Statistical Analysis

The statistical analysis for the study was carried out using IBM SPSS version 27.0. Normality assumptions of the data were assessed using the Kolmogorov-Smirnov test and Shapiro–Wilks test. Simple descriptive statistics such as mean and standard deviation were employed to calculate the SADQ-C, PACS, and MARS. Repeated measures analysis of variance (RM-ANOVA) was utilized to examine the mean differences among the various anti-craving treatment groups and across different time points. Demographic factors such as age, gender, education, and occupation were described using frequency and proportion. Pearson correlation analysis was conducted to assess the association between PACS Score and Mars Score, PACS Score, and SADQ-C Score and to determine the correlation between baclofen dosage and PACS score.

Statistically significant differences between treatment groups and at different time points were considered significant at p < .05.

Results

Retention Rate

Of the 70 participants initially recruited, 61 completed the study and were included in the final analysis, yielding a retention rate of 87.14%. Dropout occurred due to missed follow-up visits and participant non-compliance. Despite efforts to reach participants through telephonic follow-up, individuals who did not complete the required follow-up assessments were excluded from the final analysis.

Table 1 presents the study participants’ demographic, clinical, and substance use characteristics (N = 61). The majority were males (96.7%), with (65.6%) aged between 30 and 50 years. Nearly half (49.2%) began alcohol use before 20 years, while 47.5% developed dependence between 20 and 30 years. Regular alcohol use was reported by 68.9%, and binge drinking, defined as the consumption of five or more standard drinks for men (four or more for women) on a single occasion,²⁵ was common (55.7%). Severe alcohol dependence was noted in 73.8%, and baclofen was the most frequently prescribed anti-craving medication (90.2%), followed by naltrexone.

Table 1.

Demographic and Clinical Characteristics of Study Participants Diagnosed with ADS Prescribed with Anti-craving Medications.

Variable	Category	Frequency (%)
Age group (years)	<30	10 (16.4)
	30–50	40 (65.6)
	>50	11 (18.0)
Gender	Female	2 (3.3)
	Male	59 (96.7)
Age at first use (years)	<20	30 (49.2)
	20–30	23 (37.7)
	>30	8 (13.1)
Age at dependency (years)	<20	6 (9.8)
	20–30	29 (47.5)
	30–40	20 (32.8)
	>40	6 (9.8)
Frequency of alcohol use	Occasionally	19 (31.1)
	Regular	42 (68.9)
Pattern of alcohol use	Binge	34 (55.7)
	Regular	23 (37.7)
	Regular + Binge	4 (6.6)
SADQ Score	Moderate Dependence	16 (26.2)
	Severe Dependence	45 (73.8)
Anti-craving drug	Baclofen	55 (90.2)
	Naltrexone	6 (9.8)
Total		61 (100)

ADS: Alcohol Dependence Syndrome, SADQ: Severity of Alcohol Dependence Questionnaire.

The repeated measures ANOVA analysis revealed significant linear trends for PACS and MARS scores over time (within-subjects effects). Moreover, there were significant differences between subjects for both scales (between-subjects effects). These findings indicate notable changes in PACS and MARS scores over time and substantial variations among individual subjects. The correlation analysis uncovered significant findings, including a positive correlation between SADQ-C and PACS Score (r = 0.304, p = .017), signifying that elevated SADQ-C scores correspond to higher PACS scores. Conversely, there was a notable negative correlation between PACS Score and MARS Score (r = -0.757, p < .001), indicating that lower PACS scores are linked to higher MARS scores. The linear regression analysis reveals a robust correlation between the MARS and PACS scores, with an R-value of 0.757 and an R² of 0.573. The model accounts for 57.3% of the variance in PACS scores. The unstandardized coefficient for the MARS score is -0.757, with a statistically significant p value of less than .001. The 95% confidence interval for the coefficient ranges from -0.927 to -0.587, indicating that higher MARS scores are linked to lower PACS scores (Table 2).

Table 2.

Analysis of PACS, MARS, and SADQ-C Scores of Study Participants Diagnosed with ADS Prescribed with Anti-craving Medications.

Analysis Type	Variable(s)	F/r Value	p Value	Interpretation
Repeated measures ANOVA	PACS scores (within the subjects) (linear)	183.175	<.001	Significant decrease over time
	MARS scores (within the subjects) (linear)	13.943	<.001	Significant decrease over time
	PACS scores (between-subjects)	560.920	<.001	Significant variation among subjects
	MARS scores (between-subjects)	2499.971	<.001	Significant variation among subjects
Correlation analysis	SADQ C vs. PACS score	0.304	.017	Weak positive correlation
Correlation analysis	PACS score vs. MARS score	–0.757	<.001	Strong negative correlation
Regression analysis	MARS score predicting PACS score	0.757	<.001	MARS score significantly predicts PACS score
Regression analysis	R² value	0.573	–	57.3% variance in PACS explained by MARS

PACS: Penn Alcohol Craving Scale, SADQ-C: Severity of Alcohol Dependence Questionnaire, MARS: Medication Adherence rating scale, ADS: Alcohol Dependence Syndrome, ANOVA: Analysis of Variance.

The PACS score demonstrated a significant decrease from the baseline to the eighth follow-up, as depicted in Figure 1. The mean PACS score decreased from 21.66 (SD = 3.502) initially to 6.31 (SD = 5.156) at the final follow-up, indicating a consistent reduction in craving levels over time. In contrast, the MARS scores showed a less pronounced decline over the same period, as illustrated in Figure 2.

Figure 1.

PACS: Penn Alcohol Craving Scale, ADS: Alcohol Dependence Syndrome.

Figure 2.

ADS: Alcohol Dependence Syndrome, MARS: Medication Adherence Rating Scale.

The mean PACS scores for individuals prescribed Baclofen and Naltrexone were compared at eight follow-up points. The independent sample t-tests revealed no statistically significant differences between the groups at any follow-up point, with all p values exceeding .05. Specifically, the mean scores and standard deviations for baclofen ranged from 10.45 ± 4.220 at the first follow-up to 6.60 ± 5.301 at the eighth follow-up, while the mean scores for naltrexone ranged from 12.00 ± 4.336 to 3.67 ± 2.503, as depicted in Figure 3.

Figure 3.

PACS: Penn Alcohol Craving Scale, ADS: Alcohol Dependence Syndrome.

Similarly, the mean MARS scores for Baclofen and Naltrexone were compared across eight follow-up periods. The independent sample t-tests also showed no significant differences between the groups, with all p values exceeding .05. The mean scores and standard deviations for baclofen ranged from 9.78 ± 0.956 at the first follow-up to 8.51 ± 2.659 at the eighth follow-up, while the mean scores for naltrexone ranged from 10.00 ± 0.000 to 9.67 ± 0.816, as shown in Figure 4. Although baclofen was prescribed to the majority of participants (90.2%), comparisons were still conducted between the Baclofen and Naltrexone groups using independent samples t-tests, which are appropriate for groups with unequal sample sizes when assumptions of normality and homogeneity of variance were reasonably met. These analyses are exploratory, and the results were interpreted cautiously due to the smaller sample size in the Naltrexone group.

Figure 4.

MARS: Medication Adherence Rating Scale, ADS: Alcohol Dependence Syndrome.

The initial score at the first follow-up was 9.80 (SD = 0.910), decreasing to 8.62 (SD = 2.557) by the eighth follow-up. Initially, 68.9% of individuals were in a state of abstinence, which increased to 85.2% by the fifth follow-up and remained relatively stable thereafter. The percentage of individuals in abstinence in a protected environment decreased from 29.5% at the first follow-up to 3.3% by the fifth follow-up, eventually disappearing in subsequent follow-ups. Instances of Lapse began to emerge at the fifth follow-up, peaking at 3.3% in the seventh follow-up before disappearing again. The Relapse category commenced at 1.6% in the first follow-up, fluctuating and increasing to 14.8% by the seventh and eighth follow-ups (Supplementary Figure).

Discussion

The effectiveness of anti-craving medications such as Naltrexone, Baclofen, Acamprosate, and Topiramate in reducing alcohol craving has been extensively documented. This study aimed to assess changes in craving levels over three months among individuals prescribed different anti-craving medications. Of the 61 participants, most were prescribed baclofen, while a smaller subset received naltrexone. The predominance of Baclofen use may be attributed to its lower cost at 20 mg/day and 40 mg/day doses compared to the higher cost of naltrexone at 50 mg/day and 75 mg/day. Furthermore, baclofen has demonstrated favorable safety, efficacy, and tolerability profiles in individuals with liver disease. In contrast, while naltrexone is effective, its use requires caution in patients with hepatic impairment, particularly those with acute hepatitis or liver failure.²⁶ This clinical consideration likely influenced prescribing practices, given that 24.6% of the study population had a documented history of alcohol-related liver disease (ALD), and 1.6% had calcified pancreatitis. Additionally, elevated liver function test (LFT) parameters—including gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)—were observed, indicating significant hepatic stress, which is commonly seen in chronic alcohol users.

Demographically, the majority of participants were between the ages of 30 and 50, which aligns with the findings of Kumar et al. (2020).¹² In terms of gender distribution, a predominantly male population was observed in our study, consistent with the results reported by Rozatkar et al. (2016).¹⁷ This gender imbalance in alcohol dependence treatment studies reflects broader societal trends and potential gender-specific pathways to alcohol dependence that merit further exploration.

More than half of the participants reported binge drinking, with a significant portion indicating regular alcohol use. Our findings align with those of Rozatkar et al. (2016).¹⁷ However, the mean age of alcohol abuse initiation in our study was slightly younger (28.77 ± 8.95 years), suggesting a potential trend toward earlier onset. As emphasized by The Lancet Public Health (2018), early initiation of alcohol use is a critical risk factor for the development of alcohol dependence later in life.²⁷

In our study, nearly half of the participants had their first alcoholic drink before the age of 20, with a similar percentage starting regular alcohol consumption in their twenties. In contrast, Korlakunta and Reddy (2019) reported a later initiation of alcohol use, with most participants having their first drink in their late twenties, followed by a later onset of alcohol dependence.²⁸ This variation may reflect cultural or regional differences in drinking habits and the societal acceptance of alcohol use.

The assessment of alcohol dependence severity, as measured by SADQ-C scores, indicated that a significant proportion of participants exhibited severe levels of dependence. This finding contrasts with the results reported by Morley et al. (2006), which identified a predominance of moderate dependence among their study population.²⁹

The baseline mean craving levels, measured by the PACS score before starting anti-craving medication, were moderately high. After a three-month study period, there was a significant decline in PACS scores, with a notable reduction in craving. A two-independent sample t-test was performed to compare the PACS scores between the Baclofen and Naltrexone groups. The analysis revealed no statistically significant difference between the two medications. These results are consistent with findings from a study by Kumar et al. (2020), who found a rapid reduction in craving, as measured by the OCDS score, for Baclofen and Naltrexone, with no significant difference between the groups.¹²

Medication adherence, measured by the MARS, was high, with statistically significant adherence both within and between subjects (p < .05). A two-sample independent t-test showed no significant difference in MARS scores between the Baclofen and Naltrexone groups. This aligns with a study by Kumar et al. (2020), where patients’ attitudes toward Baclofen, Acamprosate, and Naltrexone (measured by the Hogan Drug Attitude Inventory) remained stable, with no significant differences between groups.¹²

Relapse rates were low in this study, with most participants maintaining abstinence after three months. These results align with Addolorato et al. (2002b), who reported similar relapse and abstinence rates for Baclofen.¹³

The current study also found that most participants were in the preparation phase of their motivational stages one week after starting anti-craving medication, with many progressing to the action phase by the end of three months. Despite early abstinence, some remained in the preparation stage, likely due to unresolved barriers or uncertainties about long-term recovery. Abstinence is influenced not only by motivation but also by craving reduction, medication adherence, and support systems. The pharmacological effect of anti-craving medications may have contributed to early abstinence, even among those still building psychological readiness. These findings differ from those of Rozatkar et al. (2016),¹⁷ who reported a higher proportion of participants in the pre-contemplation phase regarding alcohol use. The higher rates of patients in the preparation phase in our study may be attributed to the initiation of anti-craving medications following detoxification, often accompanied by motivational enhancement therapy. Chi-square analysis further revealed a significant association between motivation levels and alcohol use outcomes, underscoring the importance of motivation in the treatment of alcohol dependence.

Among six participants who received naltrexone, the dosage in this study was 50 mg/day. However, two participants required the dose escalation of 75 mg/day after a one-month follow-up, which was higher than the average reported by Kumar et al. (2020).¹² Although 50 mg/day is the standard recommended dose for naltrexone in alcohol dependence, some studies have explored higher doses to enhance therapeutic efficacy in individuals with higher baseline craving or insufficient response at standard doses. For instance, a study by Pettinati H et al. (2011), demonstrated that higher doses (up to 100 mg/day) could be beneficial in selected patients.³⁰ Baclofen dosages ranged from 20 mg to 40 mg, consistent with other studies such as Rozatkar et al. (2016).¹⁷ Notably, no significant correlation was found between Baclofen dosage and PACS scores, suggesting no dose-dependent relationship for baclofen in reducing craving (Supplementary Table 1). However, a significant correlation between PACS and MARS scores indicates that better medication adherence is associated with greater reductions in craving levels.

While both Baclofen and Naltrexone appeared effective in reducing craving and supporting abstinence, the three-month follow-up may not fully reflect long-term outcomes. Some participants relapsed after 3 to 4 months, and the limited number receiving naltrexone precluded meaningful correlation analyses between Naltrexone dosage and PACS scores.

The reduction in relapse rates may also be influenced by the concurrent use of medications such as Lorazepam, Sertraline, and Beta-blockers, often prescribed to manage withdrawal symptoms and co-occurring conditions like anxiety and depression. Lorazepam is commonly used to reduce anxiety and manage severe withdrawal, while Sertraline addresses concurrent depressive and anxiety symptoms frequently seen in individuals with alcohol dependence. Beta-blockers may be used to treat withdrawal-related hypertension and tachycardia. The combined effect of these adjunctive medications, along with anti-craving drugs, may have contributed to the observed decrease in relapse rates.

Limitations

The small sample size and specific inclusion criteria may affect the extent to which these findings can be generalized to the broader population with alcohol dependence. Differences in the severity of dependence, even among those reporting occasional alcohol use, could have influenced observed patterns of craving and medication adherence. In addition, the limited number of participants receiving naltrexone reduced the ability to assess dose-response relationships meaningfully. Moreover, the imbalance in the number of participants receiving Baclofen versus Naltrexone may have impacted the statistical power of certain comparisons and limited the generalizability of findings specific to naltrexone. Further research involving larger sample sizes, more balanced treatment groups, extended follow-up durations, and randomized study designs is warranted to confirm and build upon these results.

Conclusion

The study found that most participants were prescribed baclofen, with a smaller subset receiving naltrexone. Higher dependence severity was associated with increased craving levels. The PACS scores consistently decreased throughout follow-up, indicating a reduction in craving intensity. MARS scores remained relatively stable at the start, reflecting overall medication adherence, though an increase in variability was observed over time. Notably, higher medication adherence was linked to lower craving levels, and adherence to anti-craving medications significantly predicted craving reduction. Most participants achieved and maintained abstinence, although relapse rates increased towards the end of the study period.

Supplemental Material

Supplemental material for this article available online.

Supplemental Material

Supplemental material for this article available online.

Supplemental Material

Supplemental material for this article available online.

Footnotes

Consent to Participate

Respondents gave written consent for review and signature before starting interviews.

Consent for Publication

Not applicable.

Data Sharing Statements

Not applicable.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Declaration Regarding the Use of Generative AI

ChatGPT was used as a paraphrasing tool. We assume full responsibility for its entire content, including the parts generated by the AI tool.

Ethical Considerations

The CDSIMER Human Ethics Review Committee at Dayananda Sagar University approved our interviews (approval: CDSIMER/MR/0111/IEC/2024) on January 09, 2024.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Simultaneous Submission to Another Journal or Resource

No.

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