Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 9:29 AM
Study NCT ID:
NCT00809835
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2008-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA015969-13 | NIH | None | https://reporter.nih.gov/quic… | View |