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Completed

NCT Number: NCT01827332

Effect of Oxytocin on Craving and Therapy Response

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxytocin

Drug

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

Other names: Pitocin

Saline

Drug

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

Other names: Placebo

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 9, 2013
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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