Effect of Oxytocin on Craving and Therapy Response
This trial is active, not recruiting.
|Sponsor||Medical University of South Carolina|
|Start date||March 2013|
|End date||June 2015|
|Trial size||40 participants|
|Trial identifier||NCT01827332, 20991|
The purpose of this study is to examine the impact of a medication called oxytocin on craving, marijuana use, and therapy response in people who frequently use marijuana. .
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Therapy session satisfaction (as measured by subjective report)
time frame: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at baseline, Week 1, and Week 3 visit
Craving (as measured by subjective report)
time frame: Throughout baseline, Week 1 and Week 3 visits (approximately 2 hours)
Marijuana use (as measured by subjective report and urine toxicology)
time frame: Once at screening visit, once weekly for four weeks after that
Male or female participants from 18 years up to 65 years old.
- 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-IV criteria for current marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
- 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 study procedures. Subjects must abstain from marijuana for 24 hours prior to testing. 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.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
- Subjects who pose a current suicidal or homicidal risk.
- 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 study procedures.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
- Subjects who, in the investigator's opinion, would be unable to comply with study procedures or assessments.
|Official title||Effect of Oxytocin on Craving and Therapy Response in Marijuana-dependent Individuals|
|Principal investigator||Aimee L McRae-Clark, PharmD|
|Description||Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential additive effects with a therapy intervention have not been explored in marijuana-dependent individuals. In the proposed study, the impact of intranasal oxytocin on therapy effectiveness, drug craving, and marijuana use outcomes following a brief therapy intervention will be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve treatment satisfaction, attenuate drug craving, and decrease marijuana use.|
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