Targeting Orexin to Treat Nicotine Dependence
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Nicotine Dependence
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: A single group will undergo three study visits where, on different days, they will receive placebo, 10 mg, or 20 mg lorcaserin.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The order or medication/placebo administration will be randomized. The study staff and participant will be blinded to which medication they are receiving.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
Tobacco use leads to ~440,000 deaths and a loss of $193 billion every year in the US. This public health and economic crisis continues as no interventions effectively prevent smoking relapse. Between 40-70% of smokers are unable to maintain abstinence and 75% of those who do attain abstinence will r...
Tobacco use leads to ~440,000 deaths and a loss of $193 billion every year in the US. This public health and economic crisis continues as no interventions effectively prevent smoking relapse. Between 40-70% of smokers are unable to maintain abstinence and 75% of those who do attain abstinence will relapse within one-year. These relapse rates remain high even when using currently available cessation aids, which primarily target the cholinergic system, suggesting the need for medications with novel targets such as orexin. The current proposal will improve scientific knowledge and/or clinical practice by translating preclinical research on orexin into the clinical domain by indicating: 1) whether orexin antagonism attenuates motivational factors associated with smoking relapse, 2) whether suvorexant shows promise as a smoking cessation aid, or 3) whether suvorexant contributes too many unwanted side effects despite mitigating the motivation to smoke, thus confirming the role of orexin in nicotine dependence and indicating the need to develop more specific orexin antagonists.
Tracking Information
- NCT #
- NCT03999099
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Amy Janes, PhD Mclean Hospital
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