MedTrace Logo

Targeting Orexin to Treat Nicotine Dependence

NCT03999099 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Suvorexant 20 mg

Suvorexant at a high dose (20 mg)

DRUG

Suvorexant 10 mg

Suvorexant at a low dose (10 mg)

DRUG

Placebo oral tablet

Placebo

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Amy Janes, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999099 on ClinicalTrials.gov