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NCT00809835
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
Phase 2 trial testing Galantamine in Cocaine Dependence in 120 participants. Completed in 1 January 2015.
1 January 2015
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 December 2007 |
| Primary completion | 1 January 2015 |
| Estimated completion | 1 January 2015 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Galantamine (GALANTAMINE) — full drug profile →
- Computer Assisted Cognitive Behavioral Therapy (CBT)
Conditions studied
- Cocaine Dependence — all drugs for Cocaine Dependence →
Sponsor
Yale University
Who can join
Adults 18 to 50, any sex, with Cocaine 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.
-
Cocaine Use
Time frame: 12 weeks
Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback. -
Cocaine Abstinence
Time frame: 12 weeks
operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks
Sponsor's own description
We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dissociable neural substrates of opioid and cocaine use identified via connectome-based modelling.
Lichenstein SD, Scheinost D, Potenza MN, Carroll KM, et al · · 2021 · cited 70× · PMID 31719641 · DOI 10.1038/s41380-019-0586-y -
Galantamine and Computerized Cognitive Behavioral Therapy for Cocaine Dependence: A Randomized Clinical Trial.
Carroll KM, Nich C, DeVito EE, Shi JM, et al · · 2018 · cited 48× · PMID 29286595 · DOI 10.4088/jcp.17m11669 -
Effects of galantamine on cocaine use in chronic cocaine users.
Sofuoglu M, Carroll KM. · · 2011 · cited 23× · PMID 21477060 · DOI 10.1111/j.1521-0391.2011.00130.x
Verify or expand the search:
- PubMed search for NCT00809835
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Galantamine
Trials testing the same drug.
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- NCT04769206 — Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans · Phase 1, PHASE2 · active not recruiting
- NCT03384784 — Effect of Galantamine on Inflammation and Cognition · Phase 2 · completed
- NCT01677754 — A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy · Phase 2 · completed
Other recruiting trials for Cocaine Dependence
Currently open trials in the same condition.
- NCT06189690 — Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder · NA · recruiting
Other Yale University trials
Trials by the same sponsor.
- NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
- NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
- NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
- NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
- NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · 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)
- Trial protocol + status: ClinicalTrials.gov NCT00809835 (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 Yale University
- Last refreshed: 28 January 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/NCT00809835.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing