Effect of Oxytocin on Craving and Therapy Response

Marijuana Dependence Clinical Trial

Official title:

Effect of Oxytocin on Craving and Therapy Response in Marijuana-dependent Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01827332
• Other study ID #: 20991
• Status: Active, not recruiting
• Phase: N/A
• First received: April 2, 2013
• Last updated: December 10, 2015
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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. .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• Oxytocin
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
• Saline
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy session satisfaction (as measured by subjective report)	After each MET session, subjects will complete the Session Rating Scale (SRS, Miller et al). This scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall.	Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at baseline, Week 1, and Week 3 visit	No
Secondary	Craving (as measured by subjective report)	Subjects will be asked to rate their levels of marijuana craving using the 12-item Marijuana Craving Questionnaire.	Throughout baseline, Week 1 and Week 3 visits (approximately 2 hours)	No
Secondary	Marijuana use (as measured by subjective report and urine toxicology)	Subjects' marijuana use will be measured via self-report (Time Line Followback) and results of urine drug screening.	Once at screening visit, once weekly for four weeks after that	No