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Effect of Oxytocin on Craving and Therapy Response

Primary Purpose

Marijuana Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oxytocin

Saline

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxytocin

Saline

Arm Description

intranasal administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01827332

First Posted

April 2, 2013

Last Updated

November 14, 2016

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01827332

Brief Title

Effect of Oxytocin on Craving and Therapy Response

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Dependence

Keywords

marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Active Comparator

Arm Description

intranasal administration

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

intranasal administration

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Pitocin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Therapy Session Satisfaction (as Measured by Subjective Report)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aimee L McRae-Clark, PharmD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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Effect of Oxytocin on Craving and Therapy Response

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