Trials / Completed
CompletedNCT00809835
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development. The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Galantamine | Daily 8 mg galantamine capsule |
| BEHAVIORAL | Computer Assisted Cognitive Behavioral Therapy (CBT) | CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research. |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2008-12-17
- Last updated
- 2019-01-30
- Results posted
- 2017-06-12
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00809835. Inclusion in this directory is not an endorsement.