Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Oxytocin on Craving and Therapy Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01827332
First received: April 2, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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. .


Condition Intervention
Marijuana Dependence
Drug: Oxytocin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Oxytocin on Craving and Therapy Response in Marijuana-dependent Individuals

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Craving (as measured by subjective report) [ Time Frame: Throughout baseline, Week 1 and Week 3 visits (approximately 2 hours) ] [ Designated as safety issue: No ]
    Subjects will be asked to rate their levels of marijuana craving using the 12-item Marijuana Craving Questionnaire.

  • Marijuana use (as measured by subjective report and urine toxicology) [ Time Frame: Once at screening visit, once weekly for four weeks after that ] [ Designated as safety issue: No ]
    Subjects' marijuana use will be measured via self-report (Time Line Followback) and results of urine drug screening.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
intranasal administration
Drug: Oxytocin
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
Other Name: Pitocin
Placebo Comparator: Saline
intranasal administration
Drug: Saline
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
Other Name: Placebo

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827332

Contacts
Contact: Amanda Wagner, MA, LPC 843-792-0484 wagne@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Aimee L McRae-Clark, PharmD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Aimee L McRae-Clark, PharmD MUSC
  More Information

No publications provided

Responsible Party: Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01827332     History of Changes
Other Study ID Numbers: 20991
Study First Received: April 2, 2013
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
marijuana
substance abuse
drug abuse
marijuana dependence
drug addiction

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014