Targeting Orexin to Treat Nicotine Dependence (NCT03999099)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (18 items).
Location: McLean Hospital — Belmont, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- McLean Hospital — Belmont, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.