Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

NCT00606801 | Completed Results DMC

• 3 other identifiers: 0706002768P50DA009241B Rounsaville
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Conditions

Cocaine Abuse

Keywords

cognitive enhancers; Nootropic Agents

Outcome Measures

Primary Outcomes (9)

• Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers was measured.

  Baseline, Day 5 and Day 10

• Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The total hits were measured

  Baseline, Day 5 and Day 10

• Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The number of correct rejections was measured.

  Baseline, Day 5 and Day 10

• Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. A' is a measure of sensitivity to target sequences and it reflects probabilities of hits and false alarms to provide a score of sensitivity to the target regardless of response tendency. The scores range from 0 (bad) to 1 (good).

  Baseline, Day 5 and Day 10

• Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. B reflects the probability of hits and false alarms to provide a measure of the participants tendency to respond regardless of whether the target sequence is presented. The scores range from -1 to +1 with scores near +1 indicative of a subject that gave few false alarms.

  Baseline, Day 5 and Day 10

• Paired Associate Learning (PAL) - Stages Complete

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.

  Baseline, Day 5 and Day 10

• Paired Associate Learning (PAL) - Mean Errors

  Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.

  Baseline, Day 5 and Day 10

• Pattern Recognition Memory (PRM) - Response Time for Correct Answers

  In the PRM, the subject is presented with a series of 12 visual patterns, one at a time, in the center of the screen. These patterns are designed so that they cannot easily be given verbal labels. In the recognition phase, the subject is required to choose between a pattern they have already seen and a novel pattern. The time to correct answer was measured.

  Baseline, Day 5 and Day 10

• Pattern Recognition Memory (PRM) - Number Correct Answers

  Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern. The number of correct responses are measured.

  Baseline, Day 5 and Day 10

Secondary Outcomes (6)

• Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials

  Baseline, Day 5 and Day 10

• Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials

  Baseline, Day 5 and Day 10

• Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial

  Baseline, Day 5 and Day 10

• Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time

  Baseline, Day 5 and Day 10

• Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect

  Baseline, Day 5 and Day 10

Study Arms (2)

Galantamine 8 mg/day

ACTIVE COMPARATOR

Galantamine 8 mg/day

Drug: Galantamine

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Galantamine DRUG

Galantamine 8 mg/day

Also known as: Nivalin,, Razadyne,, Razadyne ER,, Reminyl,, Lycoremine

Galantamine 8 mg/day

placebo DRUG

sugar pill

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and females, between the ages 21 and 50
• Fulfill criteria for past cocaine dependence
• No cocaine use for the past 30 days
• No other current dependence or abuse of other drugs or alcohol
• No current medical problems and normal ECG
• Not pregnant,nor breast feeding,
• Using acceptable birth control methods.

You may not qualify if:

• Current major psychiatric illness including mood, psychotic or anxiety disorders
• History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
• Use of other medications including,drugs that slow heart rate
• Known allergy to galantamine

Sponsors & Collaborators

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

Study Sites (1)

Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Galantamine; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Relatively low medication dose and short duration of treatment. Multiple cognitive tests and outcome measures increase probability of Type 1 errors. Absence of non-addicted controls limits determination of a unique effect in abstinent users.

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D., Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 5, 2008
• Study Start: June 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 15, 2021
• Results First Posted: July 31, 2013

Record last verified: 2021-02

Locations

US (1)