Using orexin antagonists to help people quit smoking
Targeting Orexin to Treat Nicotine Dependence
This study is testing if a medication called suvorexant can help people who are trying to quit smoking by reducing their urge to smoke.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT03999099 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of orexin antagonists, specifically suvorexant, in reducing the motivation to smoke among nicotine-dependent individuals. The study aims to determine if these medications can help prevent relapse in smokers who are trying to quit. Participants will receive either suvorexant at different dosages or a placebo, and their responses will be monitored to assess the impact on smoking motivation and potential side effects. The trial seeks to translate promising preclinical findings into clinical practice for smoking cessation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-50 who smoke at least 5 cigarettes daily and are nicotine dependent.
Not a fit: Patients with current or lifetime psychotic disorders or severe substance abuse issues other than nicotine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for individuals struggling with nicotine dependence and reduce smoking relapse rates.
How similar studies have performed: While the use of orexin antagonists in smoking cessation is a novel approach, preclinical studies have shown promise in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be male and female volunteers between the ages of 18-50 * Participants must report daily smoking of at least 5 cigarettes per day over the last 6 months. * Participants must be nicotine dependent, having an FTND score greater than or equal to 4. * Participants must have an expired carbon monoxide level of 10 ppm or more on the screening day. * Participants must have an expired carbon monoxide level of no more than 10 ppm on the study visits. * Female participants must have a negative pregnancy test on all study days. Exclusion Criteria: * Participants cannot meet DSM-5 criteria for lifetime and/or current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder * Participants cannot meet DSM-5 criteria for current substance abuse disorders other than nicotine and marihuana and cannot meet criteria for current moderate or severe alcohol use disorder (as assessed by the SCID-5) * Participants cannot have positive drug and alcohol screen on each study visit other than for nicotine or marijuana. * Participants reporting marihuana use greater than 1-2 times per week will be excluded. * Participants must report no marihuana use within 24 hours of the study visit. * Participants cannot be taking any prescription medication that could impact brain function including medications that depress CNS function * Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders. * Participants cannot be pregnant or breastfeeding. * Participants must be able to read screening materials including consent form and give informed consent * Individuals with severe hepatic impairment will be excluded. * Participants cannot be obese as determined by a Body Mass Index (BMI) of 30 or greater. * Participants cannot be using a CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant) * Participants cannot have a current cardiac disorder such as palpitations, tachycardia and/or use of the cardiac medication Digoxin * Participants cannot have narcolepsy * Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls * Participants cannot have compromised respiratory function such severe obstructive sleep apnea or severe chronic obstructive pulmonary disease * Participants cannot have current major depressive disorder (within the past 6 months) and/or indorse suicidal ideation on the Beck Depression Inventory.
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Amy Janes, PhD — Mclean Hospital
- Study coordinator: Amy Janes, PhD
- Email: ajanes@mclean.harvard.edu
- Phone: (617)855-3244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.