Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Oxytocin on Craving and Therapy Response

NCTNCT01827332Other id20991

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 16 participants (actual)
Sponsor: Medical University of South Carolina · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Mar 2013
Primary completion: Jun 2015
Completion: Jul 2016
First posted: 9 Apr 2013 (estimated)
Last update posted: 2 Jan 2017 (estimated)
Conditions: Marijuana Dependence

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20132014201520162017

N/A
Effect of Oxytocin on Craving and Therapy Response
NCT01827332
Mar 2013 to Jul 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug
SalineDrug

Arms2

Active comparator
Oxytocin
intranasal administration
Placebo comparator
Saline
intranasal administration

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Therapy Session Satisfaction (as Measured by Subjective Report)

Group	Value (units on a scale)	Spread
Oxytocin	9.8	0.4
Saline	9.7	0.3

Secondary and other outcome results(1)

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

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

Group	Value (daily smoking sessions)	Spread
Oxytocin	-1.39	0.42
Saline	-0.22	0.44

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocinintranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	–	0 / 8	1 / 8
Salineintranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.	–	0 / 8	2 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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