Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT01531153
First received: December 7, 2011
Last updated: June 13, 2014
Last verified: June 2014

December 7, 2011
June 13, 2014
September 2011
September 2016   (final data collection date for primary outcome measure)
Urine Toxicology [ Time Frame: 2 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 up to two times per week for 12 weeks. This will also be given at the 1, 3 and 6 month follow up period.
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.
Complete list of historical versions of study NCT01531153 on ClinicalTrials.gov Archive Site
  • Heart Rate [ Time Frame: once a day for up to two days over 12 Weeks ] [ Designated as safety issue: Yes ]
    Pulse
  • Blood Pressure [ Time Frame: 2 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.
  • Heart Rate [ Time Frame: ones 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.
Not Provided
Not Provided
 
Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
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.

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 12 completers with 1active and 2 in follow up phase(June 2014)

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Addiction
  • Drug: Galantamine
    8mg or 16mg
    Other Names:
    • Razadyne
    • Razadyne ER
  • Drug: Placebo
    Placebo dose.
    Other Names:
    • Placebo
    • Sugar Pill
  • Active Comparator: Sugar Pill
    Sugar Pill will be compared with the active medication Galantamine
    Intervention: Drug: Placebo
  • Active Comparator: Galantamine
    Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
    Intervention: Drug: Galantamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and females, between the ages of 18 and 60
  2. 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
  3. 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
  4. Are fluent in English and have a 6th grade or higher reading level; AND
  5. Can commit to at least 13 weeks of treatment and are willing to be randomized to treatment

Exclusion Criteria:

  1. 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
  2. Current DSM-IV diagnosis of drug or alcohol dependence (other than cocaine, or tobacco)
  3. 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
  4. 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
  5. Have a screening liver function test (AST or ALT) greater than 3 times normal; OR
  6. Known allergy or adverse reaction to galantamine
Both
18 Years to 60 Years
No
United States
 
NCT01531153
1007007119, R01DA029577
Yes
Mehmet Sofuoglu, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP