Effect of Oxytocin on Craving and Therapy Response

NCT01827332 | Completed Results

• 1 other identifier: 20991
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Dependence

Keywords

marijuana; substance abuse; drug abuse; marijuana dependence; drug addiction

Outcome Measures

Primary Outcomes (1)

• Therapy Session Satisfaction (as Measured by Subjective Report)

  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.

  Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit

Secondary Outcomes (1)

• Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )

  Self-report of average daily smoking sessions at MET Session 1 and last MET session 3

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

intranasal administration

Drug: Oxytocin

Saline

PLACEBO COMPARATOR

intranasal administration

Drug: Saline

Interventions

Oxytocin DRUG

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

Also known as: Pitocin

Oxytocin

Saline DRUG

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

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Substance-Related Disorders

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Limitations included small sample size and limited generalizability as individuals with other substance use disorders were excluded from participation.

Results Point of Contact

• Title: Aimee McRae-Clark
• Organization: MUSC

mcraeal@musc.edu

843-792-5216

Study Officials

• Aimee L McRae-Clark, PharmD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2016
• Last Updated: January 2, 2017
• Results First Posted: November 11, 2016

Record last verified: 2016-11

Locations

US (1)