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Effect of Oxytocin on Craving and Therapy Response

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827332
First Posted: April 9, 2013
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
  Purpose
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.

Condition Intervention
Marijuana Dependence Drug: Oxytocin Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Aimee McRae-Clark, 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 last session visit ]
    After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session.


Secondary Outcome Measures:
  • Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions ) [ Time Frame: Self-report of average daily smoking sessions at MET Session 1 and last MET session 3 ]
    Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session.


Enrollment: 16
Study Start Date: March 2013
Study Completion Date: July 2016
Primary Completion Date: June 2015 (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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01827332


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

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
First Submitted: April 2, 2013
First Posted: April 9, 2013
Results First Submitted: September 22, 2016
Results First Posted: November 11, 2016
Last Update Posted: January 2, 2017
Last Verified: November 2016

Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
marijuana
substance abuse
drug abuse
marijuana dependence
drug addiction

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