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NCT00258479
Modafinil and Nicotine in Adolescents: Phase I Trial
Phase 1 trial testing ModafinilNicotine Replacement Therapy in Tobacco Use Disorder in 24 participants. Completed in 1 December 2011.
1 December 2011
Quick facts
| Lead sponsor | Catherine Martin, MD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 June 2003 |
| Primary completion | 1 December 2011 |
| Estimated completion | 1 December 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ModafinilNicotine Replacement Therapy — full drug profile →
- Modafinil (modafinil) — full drug profile →
Conditions studied
- Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
Sponsor
Catherine Martin, MD — full company profile →
Who can join
Adults 16 to 40, any sex, with Tobacco Use Disorder. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
Time frame: laboratory session
Sponsor's own description
Nicotine is one of the most widely abused substances in the United States. Nicotine replacement therapy (NRT) is currently an effective treatment for nicotine dependence; however, even with NRT most people fail at quitting smoking after their first attempt. Modafinil is a promising drug that may be useful in treating nicotine dependent individuals. The purpose of this study is to evaluate the safety of the combination of modafinil and NRT in treating nicotine dependent adolescent smokers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Medications Development for the Treatment of Nicotine Dependence in Individuals with Schizophrenia.
Montoya ID, Vocci F. · · 2007 · cited 6× · PMID 19194522 · DOI 10.1300/j374v03n03_09
Verify or expand the search:
- PubMed search for NCT00258479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tobacco Use Disorder
Currently open trials in the same condition.
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- 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
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 NCT00258479 (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 Catherine Martin, MD
- Last refreshed: 10 May 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/NCT00258479.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing