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NCT01926626: RIMA
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Phase 2 trial testing Nicotine Patch in Nicotine Dependence in 76 participants. Completed in 1 October 2014.
1 July 2014
Quick facts
| Lead sponsor | Jed E. Rose |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 1 September 2013 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 October 2014 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Nicotine Patch (nicotine-patch) — full drug profile →
- Moclobemide (MOCLOBEMIDE) — full drug profile →
Conditions studied
- Nicotine Dependence — all drugs for Nicotine Dependence →
Sponsor
Jed E. Rose
Who can join
Adults 18 to 65, female only, with Nicotine Dependence. 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.
-
Continuous Four-week Abstinence From Smoking
Time frame: Weeks 6-10 post quit day
Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Sponsor's own description
The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01926626
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nicotine Patch
Trials testing the same drug.
- NCT06811038 — iCanQuit Smoking Cessation Among Hispanic Adults · Phase 3 · not yet recruiting
- NCT06763536 — Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia · NA · recruiting
- NCT05587361 — Beta-Adrenergic Modulation of Drug Cue Reactivity · Phase 4 · recruiting
- NCT04839198 — Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation · NA · completed
- NCT05538910 — Defining Neurobiological Links Between Substance Use and Mental Illness · NA · recruiting
Other recruiting trials for Nicotine Dependence
Currently open trials in the same condition.
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT07250230 — Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Un · NA · recruiting
- NCT07040566 — A Trial of Varenicline for E-cigarette Cessation · Phase 2 · recruiting
- NCT07001930 — Effects of Cannabidiol on Stress and Nicotine Withdrawal · Phase 1 · recruiting
- NCT06765291 — Behavioral Intervention for Youth to Promote Vaping Cessation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01926626 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jed E. Rose
- Last refreshed: 17 August 2017
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/NCT01926626.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing