Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in reducing cocaine use as measured by cocaine urine results and self-report days of use.
Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention during the first four weeks of treatment will mediate galantamine's efficacy in reducing cocaine use.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Cognitive Enhancement as a Target for Cocaine Pharmacotherapy|
- Urine Toxicology [ Time Frame: 2 times per week for 12 weeks. Also given at 1,3,6 month followup sessions. ]Cocaine urine toxicology will be assessed up to two times per week for 12 weeks. This will also be given at the 1, 3 and 6 month follow up period.
- Heart Rate [ Time Frame: once a day for up to two days over 12 Weeks ]Pulse
- Blood Pressure [ Time Frame: 2 times a week for 12 weeks ]Blood Pressure is taken for safety reasons
- CANTAB RVIP measure [ Time Frame: Given at weeks 0, 4 8 and 12. Also given at followup month 1, 3 and 6. ]RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study.
- CANTAB SST [ Time Frame: Given at weeks 0, 4 8 and 12. Also given at followup month 1, 3 and 6. ]This is the CANTAB SST measure which evaluates response inhibition.
- Stroop [ Time Frame: Given at weeks 0, 4 8 and 12. Also given at followup month 1, 3 and 6. ]A computerized Stroop task.
- Digit Span [ Time Frame: Given at weeks 0, 4 8 and 12. Also given at followup month 1, 3 and 6. ]A paper and pencil digit span task to assess short-term memory.
|Study Start Date:||September 2011|
|Study Completion Date:||June 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Sugar Pill
Sugar Pill will be compared with the active medication Galantamine
Other Name: Sugar Pill
Active Comparator: Galantamine
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
8mg or 16mg
This will be a double-blind, placebo-controlled, randomized clinical trial. One hundred and twenty cocaine-dependent men and women will be randomized to one of three treatment groups: placebo (n=40), 8 mg/day (n=40), and 16 mg/day (n=40) of extended release (ER) galantamine. An urn randomization will be used to balance the groups for gender, severity of cocaine use (measured by days of cocaine use), baseline cognitive functioning [determined via the Shipley Institute of Living Scale (SILS)], and smoking status. Gender and severity of cocaine use have been shown to predict treatment responses in cocaine users (76). Similarly, balancing the treatment groups for baseline cognitive functioning, assessed with the SILS scores, will minimize the influence of baseline differences on cognitive outcomes (77, 78). Smoking status is also an important baseline variable, given galantamine's actions on nicotinic receptors and its potential efficacy for smoking cessation (65). The initial dose of galantamine will be 8 mg/day as a single dose, as recommended for clinical use. For those assigned to 16 mg/day, the dose of galantamine will be increased to 16 mg at the end of week 4. Treatment groups will remain on their full dosage through week 13. All participants will receive contingency management (CM) targeting treatment compliance. In three previous cocaine pharmacotherapy trials using bupropion, desipramine or levodopa, medication efficacy on cocaine use was evident only when medications were combined with CM, but not with standard care (79-81). These findings provide a strong rationale for using CM in our clinical trial.
Recruitment is continuing. This protocol was amended as of May 2014 to come to one dispensing visit and up too, two clinic visits. The payment has changed from gift cards to cash. This change should help increase the number of completers.
Currently there are 40 completers with 9 active and 6 in follow up phase. The follow up phase ended June 2016. Currently in analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531153
|United States, Connecticut|
|Department of Veterans Affairs|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D., Ph.D.||Yale University|