Early Phase 1
Completed N=30
Behavioral Effects of Pregabalin and Cannabis
Cannabis-use Disorders
Source: ClinicalTrials.gov NCT01511640 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.