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Effect of Oxytocin on Craving and Therapy Response

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ClinicalTrials.gov Identifier: NCT01827332
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : November 11, 2016
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE April 9, 2013
Results First Submitted Date  ICMJE September 22, 2016
Results First Posted Date  ICMJE November 11, 2016
Last Update Posted Date January 2, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Therapy Session Satisfaction (as Measured by Subjective Report) [ Time Frame: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session during the testing visit ]
After the 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.
Change History Complete list of historical versions of study NCT01827332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • Craving (as measured by subjective report) [ Time Frame: Throughout testing visit (approximately 2 hours) and at one week follow-up visit ]
    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 at testing visit, and once at one week follow-up visit ]
    Subjects' marijuana use will be measured via self-report (Time Line Followback) and results of urine drug screening.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oxytocin on Craving and Therapy Response
Official Title  ICMJE Effect of Oxytocin on Craving and Therapy Response in Marijuana-dependent Individuals
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Dependence
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Oxytocin
    intranasal administration
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Saline
    intranasal administration
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2013)
40
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827332
Other Study ID Numbers  ICMJE 20991
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aimee McRae-Clark, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aimee L McRae-Clark, PharmD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP