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
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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:
  • Placebo
  • Sugar Pill
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:
  • Razadyne
  • Razadyne ER

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. 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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531153

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: Marcedes Coffman, M.S.    203-932-5711 ext 4841    maracedes.coffman@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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: June 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Cocaine use decreases, increases or stays the same

Additional relevant MeSH terms:
Cocaine
Galantamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Parasympathomimetics
Autonomic Agents
Nootropic Agents

ClinicalTrials.gov processed this record on September 18, 2014