Clinical trial NCT01827332: Effect of Oxytocin on Craving and Therapy Response
Official title: Effect of Oxytocin on Craving and Therapy Response in Marijuana-dependent Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marijuana Dependence
Keywords: marijuana
substance abuse
drug abuse
marijuana dependence
drug addiction
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.

Detailed 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 and marijuana use outcomes following a brief therapy intervention will be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve treatment satisfaction and decrease marijuana use.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. 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.
3. 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.
4. Subjects must consent to random assignment.

Exclusion Criteria:

1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
2. 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.
3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
4. Subjects who pose a current suicidal or homicidal risk.
5. 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.
6. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
7. 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.
8. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
9. Subjects who, in the investigator's opinion, would be unable to comply with study procedures or assessments.

Primary outcomes:
measure: Therapy Session Satisfaction (as Measured by Subjective Report)
timeFrame: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit
Secondary outcomes:
measure: Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )
timeFrame: Self-report of average daily smoking sessions at MET Session 1 and last MET session 3
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aimee L McRae-Clark, PharmD
role: PRINCIPAL_INVESTIGATOR
References: