Behavioral Effects of Tiagabine and Cannabis

This study is currently recruiting participants.
Verified August 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky
ClinicalTrials.gov Identifier:
NCT01511640
First received: January 9, 2012
Last updated: August 14, 2013
Last verified: August 2013

January 9, 2012
August 14, 2013
January 2012
June 2014   (final data collection date for primary outcome measure)
number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 26 days ] [ Designated as safety issue: No ]
number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 38 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01511640 on ClinicalTrials.gov Archive Site
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Behavioral Effects of Tiagabine and Cannabis
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Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of tiagabine to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

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Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cannabis-use Disorders
Drug: Tiagabine
tiagabine or placebo 3x daily for duration of study
  • Experimental: Tiagabine 1
    Dose 1
    Intervention: Drug: Tiagabine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Tiagabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • regular cannabis use
  • good health other than cannabis use
  • willingness to attempt abstinence
  • effective form of birth control in female subjects
  • available for up to 6 hrs every day for three 2-week test periods with an intervening break of 9 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

  • contraindication to tiagabine
  • medical screening or history outcomes outside normal ranges or deemed clinical insignificant
Both
18 Years to 50 Years
No
Contact: Cleeve Emurian, MS 859-277-3766
United States
 
NCT01511640
K02-DA031766-01
No
Joshua A. Lile, Ph.D., University of Kentucky
University of Kentucky
Not Provided
Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky
University of Kentucky
August 2013

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