Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Behavioral Effects of Pregabalin and Cannabis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 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: May 19, 2016
Last verified: May 2016

January 9, 2012
May 19, 2016
June 2016
June 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 ] [ 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 Pregabalin and Cannabis
Not Provided
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
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: 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.
 
Not yet recruiting
13
Not Provided
June 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
Both
18 Years to 50 Years   (Adult)
No
United States
 
NCT01511640
R01DA036550
No
No
Not Provided
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
May 2016

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