Condition or disease | Intervention/treatment | Phase |
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Nicotine Dependence | Drug: Suvorexant 20 mg Drug: Suvorexant 10 mg Drug: Placebo oral tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention 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 |
Official Title: | Targeting Orexin to Treat Nicotine Dependence |
Actual Study Start Date : | September 26, 2019 |
Estimated Primary Completion Date : | May 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo |
Drug: Placebo oral tablet
Placebo
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Experimental: Suvorexant 10mg
Suvorexant 10mg oral dose
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Drug: Suvorexant 10 mg
Suvorexant at a low dose (10 mg)
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Experimental: Suvorexant 20mg
Suvorexant 20mg oral dose
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Drug: Suvorexant 20 mg
Suvorexant at a high dose (20 mg)
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy Janes, PhD | (617)855-3244 | ajanes@mclean.harvard.edu | |
Contact: Nathan Krantz, BA | (617) 855-2429 | nkrantz@mclean.harvard.edu |
United States, Massachusetts | |
McLean Hospital | Recruiting |
Belmont, Massachusetts, United States, 02478 | |
Contact: Amy C Janes, PhD 617-855-3244 ajanes@mclean.harvard.edu |
Principal Investigator: | Amy Janes, PhD | Mclean Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 16, 2019 | ||||||||
First Posted Date ICMJE | June 26, 2019 | ||||||||
Last Update Posted Date | February 21, 2020 | ||||||||
Actual Study Start Date ICMJE | September 26, 2019 | ||||||||
Estimated Primary Completion Date | May 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Somnolence [ Time Frame: approximately 4 hours post drug administration ] Stanford Sleepiness Scale (SSS)
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Targeting Orexin to Treat Nicotine Dependence | ||||||||
Official Title ICMJE | Targeting Orexin to Treat Nicotine Dependence | ||||||||
Brief Summary | Tobacco smoking continues to be the primary cause of preventable mortality in the United States. Despite the availability of smoking cessation aids, the majority of those trying to quit smoking end up relapsing. Thus, there is a strong need to evaluate alternative treatment targets such as orexin antagonists, which have shown promise in preclinical models at reducing the motivational aspects of drug use.The current work will evaluate the influence of orexin antagonism on several factors impacting the motivation to smoke. | ||||||||
Detailed 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 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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention 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
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Condition ICMJE | Nicotine Dependence | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
45 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2021 | ||||||||
Estimated Primary Completion Date | May 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03999099 | ||||||||
Other Study ID Numbers ICMJE | Orexin and Nicotine | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Amy C. Janes, Mclean Hospital | ||||||||
Study Sponsor ICMJE | Mclean Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Mclean Hospital | ||||||||
Verification Date | February 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |