Galantamine Effects on Cognitive Function in Marijuana Users

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00969696
First received: August 31, 2009
Last updated: July 24, 2012
Last verified: July 2012

August 31, 2009
July 24, 2012
August 2009
June 2011   (final data collection date for primary outcome measure)
test whether galantamine in comparison to placebo, will improve cognitive functioning and the effects of galantamine on mood. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00969696 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Galantamine Effects on Cognitive Function in Marijuana Users
Galantamine Effects on Cognitive Function in Marijuana Users

To evaluate galantamine's effects on cognitive performance in marijuana users. Galantamine, an acetylcholine esterase inhibitor, is approved for treatment of Alzheimer's disease. Current marijuana users show impaired cognitive functioning, which predicts poor treatment response to behavioral treatments in this population. Whether cognitive impairment in marijuana users will improve with medication treatment has not been evaluated. We hypothesize that galantamine, compared to placebo, will improve cognitive performance in marijuana users.Galantamine, compared to placebo, will improve working memory, verbal learning/memory and response inhibition functions in marijuana users.

To summarize, marijuana users show impaired cognitive functioning, especially in working memory and verbal learning and memory functions. Impaired cognitive functioning predicts poor treatment response in marijuana users. Whether the cognitive impairments in marijuana users improve with cholinergic enhancers has not been evaluated. In this double-blind, parallel-group study, we are proposing to evaluate galantamine's effects on cognitive performance in marijuana users. Thirty subjects will first have an adaptation session to familiarize them with the study procedures including cognitive assessment. The adaptation session will be followed by a 10-day treatment period, in which subjects will be randomized to galantamine (8 mg/day) or placebo. On Day 4 or 5 and Day 9 or10 of each treatment phase subjects will have test sessions, where a battery of cognitive tests will be administered. The cognitive test that will be administered will include the Hopkins Verbal Learning Test (HVLT) modules from the Cambridge Neuropsychological Test Automated Battery (CANTAB): the Rapid Visual Information Processing (RVIP) and the Stop Signal Test (SST).

Currently this study is in data analysis with 30 completers. (April 2011)

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Memory
  • Drug: Placebo
    8Mg a day of a sugar pill
  • Drug: Galantamine
    8mg of Galantamine
  • Active Comparator: Galatamine
    Galantamine is used for the treatment of mild to moderate Alzheimer's disease and various other memory
    Intervention: Drug: Galantamine
  • Placebo Comparator: Sugar Pill
    Sugar Pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women between the ages of 18 and 55 who are dependent on or abuse marijuana, according to DSM-IV criteria;
  • History of marijuana use on the average of at least twice a week over a one-month period;
  • Current marijuana use, indicated by positive urine toxicology for marijuana;
  • No current medical problems and normal ECG;
  • For women, neither pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

  • Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
  • Current dependence to other drugs of abuse or alcohol (except nicotine or marijuana dependence);
  • 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 or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
  • Use of other medications including a) drugs that slow heart rate (eg, beta-blockers),which may increase the risk of bradycardia and AV block and b) NSAIDs; increased potential for developing ulcers/active or occult gastrointestinal bleeding;
  • Known allergy to galantamine
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00969696
0905005104, P50DA009241, MIREC
Yes
Mehmet Sofuoglu, Yale University
Yale University
  • National Institute on Drug Abuse (NIDA)
  • Department of Veterans Affairs
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
July 2012

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