Randomized Placebo-Controlled Clinical Trials Testing Gemfibrozil for Smoking Cessation and Melatonin for Alcohol-related Sleeping Problems
Abstract
Substance use disorder (SUD) is not a temporary condition but it is a chronic and relapsing disorder that leads to serious health risks. SUD is considered a pathological behavior, affecting the reward circuit and stress system, and these impairments can last for a longer period even after detoxification and abstinence. The motivation behind exploring new therapeutic options for different kind of SUDs and their complications is the limited success of the available treatments. For instance, the Food and Drug Administration (FDA) approved medications for Tobacco use disorder (TUD) increase abstinence rates; however, relapse remains the most likely outcome, with success rates of only 20-30% at 1 year post-treatment follow up. The other motivation for exploring new therapeutics is the harmful side effects caused by current medications; for instance, the use of benzodiazepine receptor agonists, to treat alcohol use disorder (AUD)-sleep disorder, which are known to be addictive. This thesis focuses on two randomized clinical trials (RCTs) exploring the effect of two therapeutic options one for TUD using lab paradigms for nicotine craving and reinforcement and a brief quit attempt. The other RCT is exploring the effect of melatonin for sleep problems in AUD subjects for four weeks of treatments monitoring iii sleep quality versus placebo. The result of the 1st clinical trial showed no significant effect of gemfibrozil versus placebo on TUD lab indices. The 2nd clinical trial showed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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