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Behavioral Effects of Pregabalin and Cannabis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01511640
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis-use Disorders Drug: Pregabalin Drug: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Behavioral Effects of Drugs (Outpatient)(43)
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pregabalin 1
Dose 1
 Drug: Pregabalin
pregabalin 2x daily for duration of study
Placebo Comparator: Placebo 1
Placebo 1
 Drug: Placebo
placebo 2x daily for duration of study
Experimental: Pregabalin 2
Dose 2
 Drug: Pregabalin
pregabalin 2x daily for duration of study
Placebo Comparator: Placebo 2
Placebo 2
 Drug: Placebo
placebo 2x daily for duration of study


Outcome Measures
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Primary Outcome Measures :
  1. Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions [ Time Frame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. ]
    The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 7-10 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

  • medical screening outcomes outside normal ranges or deemed clinically insignificant
  • medical history that would contraindicate pregabalin administration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511640


Locations
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United States, Kentucky
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, United States, 40536-0086
Sponsors and Collaborators
Joshua A. Lile, Ph.D.
Investigators
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Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky
  Study Documents (Full-Text)

Documents provided by Joshua A. Lile, Ph.D., University of Kentucky:
Study Protocol and Statistical Analysis Plan  [PDF] October 28, 2020

More Information
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Responsible Party: Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science, University of Kentucky
ClinicalTrials.gov Identifier: NCT01511640    
Other Study ID Numbers: R01DA036550 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2012    Key Record Dates
Results First Posted: September 10, 2021
Last Update Posted: September 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua A. Lile, Ph.D., University of Kentucky:
marijuana
addiction
treatment
pharmacotherapy
cannabinoid
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs