Early Phase 1 N=30 Randomized Double-blind Basic Science

Behavioral Effects of Pregabalin and Cannabis

Cannabis-use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01511640 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions — 2.00; 2.67; 3.60; 4.00 Cannabis puffs

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Pregabalin (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Joshua A. Lile, Ph.D.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions	2.00; 2.67; 3.60; 4.00; 5.75; 5.67	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01511640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.