Effect of ramelteon on smoking abstinence

Effect of ramelteon on smoking abstinence

Brief description of study

There is a need for novel approaches to optimize smoking cessation treatment to help more smokers quit. Sleep disturbance during nicotine withdrawal may be an important treatment target since existing treatments do not mitigate withdrawal-related sleep disturbance and difficulty sleeping predicts smoking relapse. We hypothesize that the FDA-approved melatonin receptor agonist, ramelteon, combined with transdermal nicotine replacement therapy (TN), will promote abstinence by attenuating withdrawal-related sleep disturbance. Using a well-validated medication screening paradigm, we propose a within-subject, placebo-controlled crossover design with one within-subjects factor of medication (ramelteon vs. placebo). Treatment-seeking smokers (n=50) will complete this 6-week study (two 2-week phases separated by a 2-week washout). Each phase includes 1 week of ad libitum smoking (baseline) and 1 week of medication (8mg ramelteon or placebo) plus TN while trying to abstain (quit assessment). Small monetary incentives will be provided for biochemically-confirmed abstinence. Subjects will keep daily sleep diaries and wear an armband while sleeping which provides objective indices of sleep (SensewearPro). The primary outcome will be the number of biochemically-confirmed days abstinent (out of five). Intermediate outcomes include sleep onset latency (self-report) and sleep efficiency (SensewearPro armband). These data will lay the foundation for a larger Phase IIb clinical trial.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    TBD,tbd,tbd
  • Age: Between 18 Years - 65 Years
  • Gender: All
Updated on 04 Sep 2018. Study ID: 823286

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