Phase II Study on Cannabidiol Plus Naltrexone to Reduce Alcohol Craving in Adults with Alcohol Dependence

What this Trial Is About

Researchers are investigating the effects of combining Cannabidiol CBD with Naltrexone NTX on alcohol craving in people with alcohol dependence, a chronic condition with limited treatment options. This phase II, randomized, double-blind, placebo-controlled trial aims to evaluate whether two different doses of CBD 800mg and 1200mg, when added to standard NTX treatment 50mg daily, reduce alcohol craving more than NTX alone over a 14-day treatment period. The study focuses on patients who experience high alcohol craving and includes assessments of quality of life and biological markers related to craving as secondary outcomes. Participants will be randomly assigned to one of three groups one receiving 800mg CBD plus 50mg NTX daily, another receiving 1200mg CBD plus 50mg NTX daily, and a third receiving placebo capsules plus 50mg NTX daily. All treatments are given orally during an inpatient addiction treatment program following current guidelines. The 14-day treatment period is part of a standardized care program, designed to evaluate the added effect of CBD on top of NTX. During the study, participants will be assessed at multiple visits including baseline, during treatment days 1, 7, and 14, and follow-up visits at days 28, 42, 105, and 196. Researchers will measure alcohol craving using the Obsessive Compulsive Drinking Scale, along with quality of life, depression, anxiety, patient-reported outcomes, blood CBD levels, brain imaging, and drinking behavior. Safety is monitored through reports of adverse events. These evaluations aim to understand the treatment impact on craving and long-term outcomes over about seven months.

A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence