Pregnenolone and Marijuana Dependence

NCT02439814 | Completed Phase 2 Results

• 1 other identifier: PRO42135
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Marijuana Dependence

Outcome Measures

Primary Outcomes (1)

• Subjective Rating of Marijuana Craving on 1-7 Likert Scale

  Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.

  12:40 to 14:45 (post med administration, post Marijuana cue

Study Arms (2)

Pregnenolone

EXPERIMENTAL

Drug: Pregnenolone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Pregnenolone DRUG

Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication

Pregnenolone

Placebo OTHER

Inactive comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Results Point of Contact

• Title: Dr. McRae-Clark
• Organization: Medical University of South Carolina

mcraeal@musc.edu

843-792-5216

Study Officials

• Aimee McRae-Clark, PharmD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 18, 2018
• Results First Posted: June 18, 2018

Record last verified: 2018-05

Locations

US (1)