Effectiveness of Naltrexone and Baclofen Combination in Reducing Craving among Patients with Alcohol Dependence: An Open-label Trial.

OBJECTIVE

Alcohol use disorder is among the most prevalent mental disorders worldwide. Craving, a key feature of alcohol dependence, is also a major reason for relapse. We aimed to determine the efficacy of naltrexone, baclofen, and naltrexone-baclofen combination in reducing craving among patients with alcohol dependence.

METHODS

In this open-label, randomised trial of eight weeks duration, 97 participants were randomly allocated to three groups, namely naltrexone alone, baclofen alone, and naltrexone-baclofen combination, using a computer-generated random number table. The dosage was 40 to 60 mg/day for baclofen and 50 mg a day for naltrexone. Tools used for assessment included the Obsessive Compulsive Drinking Scale (OCDS), the visual analogue scale (VAS) for craving, World Health Organization Quality of Life BREF (WHOQoL BREF), and World Health Organization Well-being Scale (WHO-5). Mixed design ANOVA was used for analysis.

RESULTS

The naltrexone-baclofen combination group had a significantly greater decline in OCDS score as compared to the naltrexone group, but not as compared to the baclofen alone group. Also, there was a greater reduction in VAS, WHOQoL BREF, and WHO-5 score in the naltrexone-baclofen group compared to the other two groups; however, the difference was not significant. No significant differences were found in relapse rates and heavy episodic drinking between groups.

CONCLUSION

The naltrexone-baclofen combination may be better in comparison to naltrexone used alone in reducing craving in alcohol dependence and is well tolerated.