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NCT00617201
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Phase 2 trial testing atomoxetine in Substance Abuse in 50 participants. Completed in 1 August 2011.
1 August 2011
Quick facts
| Lead sponsor | Sharon Walsh |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 July 2007 |
| Primary completion | 1 August 2011 |
| Estimated completion | 1 August 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- atomoxetine (ATOMOXETINE) — full drug profile →
- placebo
Conditions studied
- Substance Abuse — all drugs for Substance Abuse →
Sponsor
Sharon Walsh — full company profile →
Who can join
Adults 18 to 60, any sex, with Substance Abuse. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
% Urine Samples Negative for Cocaine
Time frame: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Total % urine samples negative for benzoylecgonine over the 12-week trial
Sponsor's own description
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Atomoxetine does not alter cocaine use in cocaine dependent individuals: double blind randomized trial.
Walsh SL, Middleton LS, Wong CJ, Nuzzo PA, et al · · 2013 · cited 26× · PMID 23200303 · DOI 10.1016/j.drugalcdep.2012.10.024
Verify or expand the search:
- PubMed search for NCT00617201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sharon Walsh trials
Trials by the same sponsor.
- NCT04300751 — The Behavioral Effects of Opioids and Alcohol · Phase 1 · completed
- NCT04315181 — Prescription Medication Interactions · Phase 1 · completed
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 NCT00617201 (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 Sharon Walsh
- Last refreshed: 1 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/NCT00617201.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing