Tobacco Use Disorder Clinical Trial
Official title:
Repurposing Melatonin Receptor Agonists as Adjunct Treatments for Smoking Cessation
This is a randomized, double-blind, placebo-controlled crossover study to test whether a medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it reduces sleep problems that smokers experience during a quit attempt.
Ramelteon, an FDA-approved treatment for insomnia, is used to treat sleep problems (e.g.,
specifically sleep onset latency) by enhancing melatonin receptor function. The investigators
propose a randomized double-blind placebo-controlled crossover study.
Fifty chronic smokers will complete a validated procedure for screening new medications. All
subjects will receive 8mg ramelteon and placebo. The order in which ramelteon and placebo is
received will be randomized across participants. This is a 6-week study consisting of two
2-week medication phases separated by a 2-week washout. Each phase includes 1 week of ad
libitum smoking (baseline) and 1 week of medication (ramelteon vs. placebo) plus transdermal
nicotine patches while trying to abstain from smoking (quit assessment). Subjects will
complete the same procedures during each study phase. Following completion of the study,
participants will be offered standard smoking cessation treatment.
For the duration of the study, subjects will be asked to keep sleep diaries and to wear an
armband while sleeping, which provides objective indices of sleep duration and quality
(SensewearPro® armband).
The primary outcome will be the total number of days abstinent (out of 5) during each quit
assessment period. Intermediate outcomes include sleep onset latency (self-report) and sleep
efficiency (SensewearPro®).
This study will provide information about the role of the melatonin system during brief
abstinence and whether enhancing melatonin reduces abstinence-induced sleep problems that
promote smoking relapse. Information obtained in this study may further establish the role of
sleep disturbance in promoting smoking relapse.
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