Phase 2
N=21
Pregnenolone and Marijuana Dependence
Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02439814 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Subjective Rating of Marijuana Craving on 1-7 Likert Scale — 1.64; 0.80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pregnenolone (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Rating of Marijuana Craving on 1-7 Likert Scale |
1.64; 0.80 | — |
Summary
The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of marijuana. THC is believed to be a significant factor in the addictive potential associated with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been found in alcohol-dependent individuals as compared to social drinkers, suggesting that changes in the sensitivity of the endogenous endocannabinoid system play a role in the transition from recreational drug use to substance use disorders. Thus, pharmacotherapies that target the cannabinoid system may be effective strategies for reducing marijuana use and dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG) inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This pilot study will provide important preliminary data on the effect of an acute dose of PREG on cue-related craving in individuals with cannabis use disorder.
Eligibility Criteria
General Inclusion / Exclusion Criteria Inclusion Criteria
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must meet DSM-5 criteria for current cannabis use disorder (within the past three months). While individuals may endorse use of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for any other substance use disorder (except nicotine) within the last 60 days. Due to the high comorbidity of marijuana and alcohol use disorder, subjects who meet criteria for mild alcohol use disorder will be included.
- Subjects must consent to remain abstinent from alcohol for 24 hours and other drugs of abuse (except nicotine and marijuana) for three days immediately prior to the study visit. Subjects must abstain from marijuana for 24 hours prior to the study visit. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana.
- Subjects must consent to random assignment.
Exclusion Criteria
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Individuals taking exogenous gonadal steroids including estrogens, progestins and testosterone. This includes hormonal contraception and replacement therapy.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, neurological disease including diabetes or cancer, as these conditions may affect study outcomes.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
- Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Individuals who take stimulants for treatment of ADHD will be allowed to participate.
- Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and marijuana for 24 hours and other drugs of abuse (except nicotine) for three days prior to the study visit.
- Subjects meeting DSM-5 criteria for a substance use disorder (other than nicotine, marijuana, or alcohol) within the past 60 days.
Data sourced from ClinicalTrials.gov (NCT02439814). 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.