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Behavioral Effects of Pregabalin and Cannabis

This study is currently recruiting participants.
Verified May 2017 by Joshua A. Lile, Ph.D., University of Kentucky
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511640
First Posted: January 18, 2012
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky
January 9, 2012
January 18, 2012
May 3, 2017
February 1, 2017
June 30, 2019   (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: 22 days ]
number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 38 days ]
Complete list of historical versions of study NCT01511640 on ClinicalTrials.gov Archive Site
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Behavioral Effects of Pregabalin and Cannabis
Behavioral Effects of Drugs (Outpatient)(43)
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 pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Cannabis-use Disorders
  • Drug: Pregabalin
    pregabalin 2x daily for duration of study
  • Drug: Placebo
    placebo 2x daily for duration of study
  • Experimental: Pregabalin 1
    Dose 1
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Placebo
    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.
 
Recruiting
13
December 31, 2019
June 30, 2019   (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 two 2-week test periods with an intervening break of 10 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

  • medical screening outcomes outside normal ranges or deemed clinical insignificant
  • medical history that would contraindicate pregabalin administration
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
United States
 
 
NCT01511640
R01DA036550( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Joshua A. Lile, Ph.D., University of Kentucky
Joshua A. Lile, Ph.D.
Not Provided
Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky
University of Kentucky
May 2017

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