Behavioral Effects of Pregabalin and Cannabis

Joshua A. Lile, Ph.D.

Status and phase: Completed; Early Phase 1

Conditions: Cannabis-use Disorders

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT01511640

R01DA036550

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Pregabalin 1

Experimental group

Description:

Dose 1

Treatment:

Drug: Pregabalin

Placebo 1

Placebo Comparator group

Description:

Placebo 1

Treatment:

Drug: Placebo

Pregabalin 2

Experimental group

Description:

Dose 2

Treatment:

Drug: Pregabalin

Placebo 2

Placebo Comparator group

Description:

Placebo 2

Treatment:

Drug: Placebo