Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Addiction |
Drug: Galantamine Drug: Placebo |
| Study Type: | Interventional |
| 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: 3 times per week for 12 weeks. Also given at 1,3,6 month followup sessions. ] [ Designated as safety issue: No ]Cocaine urine toxicology will be assessed 3 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 three days over 12 Weeks ] [ Designated as safety issue: Yes ]Pulse
- Blood Pressure [ Time Frame: 3 times a week for 12 weeks ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]A paper and pencil digit span task to assess short-term memory.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sugar Pill
Sugar Pill will be compared with the active medication Galantamine
|
Drug: Placebo
Placebo dose.
Other Names:
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Active Comparator: Galantamine
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
|
Drug: Galantamine
8mg or 16mg
Other Names:
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Detailed Description:
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. Currently there are 8 completers with 2 active (February 2013)
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and females, between the ages of 18 and 55
- Are using cocaine more than once per week in the previous 30 days, provide a cocaine-positive urine specimen at screening, and fulfill criteria for current cocaine dependence according to DSM-IV
- For women of child-bearing age, have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly pregnancy tests
- Are fluent in English and have a 6th grade or higher reading level; AND
- Can commit to at least 12 weeks of treatment and are willing to be randomized to treatment
Exclusion Criteria:
- Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued
- Current DSM-IV diagnosis of drug or alcohol dependence (other than cocaine, or tobacco)
- Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal deficit and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment
Use of other medications including:
- drugs that slow heart rate (e.g., beta-blockers), which may increase the risk of bradycardia and atrioventricular (AV) block and
- non-steroidal anti-inflammatory drugs (NSAIDs); increased potential for developing ulcers/active or occult gastrointestinal bleeding
- Have a screening liver function test (AST or ALT) greater than 3 times normal; OR
- Known allergy or adverse reaction to galantamine
Contacts and Locations| United States, Connecticut | |
| Department of Veterans Affairs | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Lance Barnes 203-937-4823 lance.barnes@yale.edu | |
| Contact: Katherine Barrett, B.S., LADC 203-932-5711 ext 5972 Katherine.Barrett@va.gov | |
| Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
More Information
No publications provided
| Responsible Party: | Mehmet Sofuoglu, Principle Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT01531153 History of Changes |
| Other Study ID Numbers: | 1007007119, R01DA029577 |
| Study First Received: | December 7, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
Cocaine use decreases, increases or stays the same |
Additional relevant MeSH terms:
|
Behavior, Addictive Compulsive Behavior Impulsive Behavior Cocaine Galantamine Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |
Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Parasympathomimetics Autonomic Agents Nootropic Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents |
ClinicalTrials.gov processed this record on June 17, 2013