Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

NCT01531153 | Completed Results DMC

• 2 other identifiers: 1007007119R01DA029577
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Addiction

Keywords

Cocaine use decreases, increases or stays the same

Outcome Measures

Primary Outcomes (1)

• Urine Toxicology

  Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.

  12 weeks

Secondary Outcomes (16)

• Heart Rate

  once a day for up to two days over 12 Weeks

• Blood Pressure- Systolic

  2 times a week for 12 weeks

• Blood Pressure- Diastolic

  2 times a week for 12 weeks

• CANTAB RVIP Measure: RVP A

  Baseline and 12 Weeks

• CANTAB RVIP Measure: RVP B

  Baseline and 12 Weeks

Study Arms (2)

Sugar Pill

ACTIVE COMPARATOR

Sugar Pill will be compared with the active medication Galantamine

Drug: Placebo

Galantamine

ACTIVE COMPARATOR

Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.

Drug: Galantamine

Interventions

Galantamine DRUG

8mg or 16mg

Also known as: Razadyne, Razadyne ER

Galantamine

Placebo DRUG

Placebo dose.

Also known as: Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and females, between the ages of 18 and 60
• 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 13 weeks of treatment and are willing to be randomized to treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Galantamine; Sugars

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Results Point of Contact

• Title: Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed
• Organization: Yale University

mehmet.sofuoglu@yale.edu

(203) 937-4809

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: February 10, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-10

Locations

US (1)