Pregnenolone and Marijuana Dependence
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|ClinicalTrials.gov Identifier: NCT02439814|
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : June 18, 2018
Last Update Posted : June 18, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Marijuana Dependence||Drug: Pregnenolone Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Pregnenolone on Cue-reactivity in Marijuana-dependent Individuals|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
|Placebo Comparator: Placebo||
- Subjective Rating of Marijuana Craving on 1-7 Likert Scale [ Time Frame: 12:40 to 14:45 (post med administration, post Marijuana cue ]Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439814
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||Aimee McRae-Clark, PharmD||Medical University of South Carolina|
|Responsible Party:||Medical University of South Carolina|
|Other Study ID Numbers:||
|First Posted:||May 12, 2015 Key Record Dates|
|Results First Posted:||June 18, 2018|
|Last Update Posted:||June 18, 2018|
|Last Verified:||May 2018|