Behavioral Effects of Pregabalin and Cannabis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-03-15

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.

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Detailed Description

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Conditions

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Cannabis-use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pregabalin 1

Dose 1

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

pregabalin 2x daily for duration of study

Placebo 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 2x daily for duration of study

Pregabalin 2

Dose 2

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

pregabalin 2x daily for duration of study

Placebo 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 2x daily for duration of study

Interventions

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Pregabalin

pregabalin 2x daily for duration of study

Intervention Type DRUG

Placebo

placebo 2x daily for duration of study

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No