Effect of Ramelteon on Smoking Abstinence (RAP)
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|ClinicalTrials.gov Identifier: NCT02560324|
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Ramelteon Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Repurposing Melatonin Receptor Agonists as Adjunct Treatments for Smoking Cessation|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
The study will be performed using 8mg of ramelteon, which is currently marketed for the treatment of sleep problems. The proposed study follows the typical dosing regimen for ramelteon (8mg once a day) for 5 days during each quit assessment period.
Ramelteon will be purchased and packaged into blister packs by the Investigational Drug Service (IDS) at the University of Pennsylvania. In accordance with FDA recommendations, subjects will be instructed to take study medication within 30 min prior to going to bed and avoid taking study medication with or immediately after a high fat meal.
Placebo Comparator: Placebo
5-day placebo-controlled medication period.
Placebo ingredients will be purchased, encapsulated, and packaged into blister packs by the IDS at UPenn. Both active medication and placebo will look identical.
The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take ramelteon during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by ramelteon during the second medication period.
Other Name: Sugar Pill
- Total number of smoke-free days (biochemically verified) during each 5-day quit assessment. [ Time Frame: Week 2 and Week 5 ]The quit assessment will begin the Monday morning of each quit week and will end that Friday. The total number of days of abstinence will be assessed.
- Subjective sleep disturbance [ Time Frame: Week 2 and Week 6 ]Sleep onset latency will be assessed via daily sleep diaries during each quit assessment.
- Objective sleep disturbance [ Time Frame: Week 2 and Week 6 ]Sleep efficiency (the ratio of time spent asleep to the total time in bed) will be assessed via the SensewearPro armbands during each quit assessment.
- Side effects of ramelteon [ Time Frame: Baseline (weeks 1 and 5); Quit assessments (weeks 2 and 6) ]Side effects will be assessed at each in-person visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560324
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Rebecca Ashare, Ph.D.||University of Pennsylvania|