Phase 2
Completed N=120
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Cocaine Dependence
Source: ClinicalTrials.gov NCT00809835 ↗
Enrolled (actual)
120
Serious AEs
17.5%
Results posted
Jun 2017
Primary outcomePrimary: Cocaine Use — 18.82; 14.81; 15.68; 14.85 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use |
18.82; 14.81; 15.68; 14.85; 8.60; 6.32 | — |
| PRIMARY Cocaine Abstinence |
22.45; 31.13; 20.49; 14.78 | — |
| SECONDARY Cognitive Function |
-.12; .11; -.06; .03 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females between ages of 18 and 50
- Enrolled in RNP methadone program and stable on methadone for at least 3 weeks
- Current cocaine abuse or dependence according to DSM-IV criteria
- No current medical problems and normal ECG
- If female, not currently pregnant or breast feeding and using reliable birth control
- Fluent in English and have at least a 6th grade reading level
- Can commit to 12 weeks of treatment and are willing to be randomized
Exclusion Criteria
- Current major psychiatric illness including mood, psychotic or anxiety disorder
- History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances
- Use of medications including beta blockers and NASAIDs
- Known allergy to Galantamine
Data sourced from ClinicalTrials.gov (NCT00809835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.