NCT02560324 (RAP) is a Phase 2 clinical trial of Ramelteon in Tobacco Use Disorder, sponsored by University of Pennsylvania.

Who is sponsoring NCT02560324?

NCT02560324 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT02560324?

Interventions in NCT02560324: Ramelteon, Placebo.

What condition does NCT02560324 study?

NCT02560324 studies Tobacco Use Disorder.

Is NCT02560324 still recruiting?

NCT02560324 is currently completed. Last updated 1 November 2019.

Are results published for NCT02560324?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-01 · How we verify

NCT02560324: RAP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Repurposing Melatonin Receptor Agonists as Adjunct Treatments for Smoking Cessation

Completed Phase 2 Results posted Last updated 1 November 2019

What this trial tests

Phase 2 trial testing Ramelteon in Tobacco Use Disorder in 140 participants. Completed in 1 August 2018.

Timeline

1 September 2015

Primary endpoint
1 August 2018

1 August 2018

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	140
Start date	1 September 2015
Primary completion	1 August 2018
Estimated completion	1 August 2018
Sites	1 location across United States

Drugs / interventions tested

Ramelteon (RAMELTEON) — full drug profile →
Placebo

Conditions studied

Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Total Number of Smoke-free Days (Biochemically Verified) During Each 5-day Quit Assessment.
Time frame: Week 2 and Week 6
The quit assessment will begin the Monday morning of each quit week and will end that Friday. The total number of days of abstinence will be assessed.

Sponsor's own description

This is a randomized, double-blind, placebo-controlled crossover study to test whether a medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it reduces sleep problems that smokers experience during a quit attempt.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacodynamics and Systems Pharmacology Approaches to Repurposing Drugs in the Wake of Global Health Burden.
Bai JPF. · · 2016 · cited 7× · PMID 27522921 · DOI 10.1016/j.xphs.2016.07.004

Verify or expand the search:

Other trials of Ramelteon

Trials testing the same drug.

NCT07382843 — Melatonin Agonist for Shift-time Workers. · Phase 4 · completed
NCT03165695 — Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults · Phase 4 · withdrawn
NCT03931070 — The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU · Phase 4 · completed
NCT03265951 — Ramelteon for Complex Insomnia in Veterans With PTSD · Phase 4 · withdrawn
NCT02669082 — The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Usi · Phase 4 · completed

Other recruiting trials for Tobacco Use Disorder

Currently open trials in the same condition.

NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting

Other University of Pennsylvania trials

Trials by the same sponsor.

NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
NCT07415772 — Effect of cTBS on Startle and TMS-evoked BOLD · NA · not yet recruiting
NCT07489430 — DaxibotulinumtoxinA for Blepharospasm · Phase 2 · not yet recruiting
NCT07463131 — Negative Income Tax Trial · NA · not yet recruiting
NCT06645769 — Na-Phenylbutyrate VAscular Trial · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02560324 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 1 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02560324.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing