Behavioral Effects of Pregabalin and Cannabis

Study Overview
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Brief Summary
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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 pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

Official Title
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Behavioral Effects of Drugs (Outpatient)(43)

Conditions
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Cannabis-use Disorders

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin 1<br>Dose 1 | Drug: Pregabalin<br>* pregabalin 2x daily for duration of study<br>|
| Placebo Comparator: Placebo 1<br>Placebo 1 | Drug: Placebo<br>* placebo 2x daily for duration of study<br>|
| Experimental: Pregabalin 2<br>Dose 2 | Drug: Pregabalin<br>* pregabalin 2x daily for duration of study<br>|
| Placebo Comparator: Placebo 2<br>Placebo 2 | Drug: Placebo<br>* placebo 2x daily for duration of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 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. | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marijuana, addiction, treatment, pharmacotherapy, cannabinoid