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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Marijuana Dependence
Interventions Drug: Oxytocin
Drug: Saline
Enrollment 16
Recruitment Details Participants recruited between July 2014 and May 2015 primarily through media and internet advertisements.
Pre-assignment Details  
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

intranasal administration

Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.

intranasal administration

Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.

Period Title: Overall Study
Started 8 8
Completed 6 7
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Oxytocin Saline Total
Hide Arm/Group Description

intranasal administration

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

intranasal administration

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

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
3
  37.5%
3
  37.5%
6
  37.5%
Male
5
  62.5%
5
  62.5%
10
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Therapy Session Satisfaction (as Measured by Subjective Report)
Hide 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.
Time Frame Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

intranasal administration

Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.

intranasal administration

Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.

Overall Number of Participants Analyzed 6 7
Mean (Standard Error)
Unit of Measure: units on a scale
9.8  (0.4) 9.7  (0.3)
2.Secondary Outcome
Title Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )
Hide 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.
Time Frame Self-report of average daily smoking sessions at MET Session 1 and last MET session 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

intranasal administration

Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.

intranasal administration

Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.

Overall Number of Participants Analyzed 6 7
Mean (Standard Error)
Unit of Measure: daily smoking sessions
-1.39  (0.42) -0.22  (0.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

intranasal administration

Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.

intranasal administration

Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.

All-Cause Mortality
Oxytocin Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      2/8 (25.00%)    
General disorders     
Headache *  0/8 (0.00%)  0 2/8 (25.00%)  2
Skin and subcutaneous tissue disorders     
Other *  1/8 (12.50%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Limitations included small sample size and limited generalizability as individuals with other substance use disorders were excluded from participation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aimee McRae-Clark
Organization: MUSC
Phone: 843-792-5216
EMail: mcraeal@musc.edu
Layout table for additonal information
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01827332     History of Changes
Other Study ID Numbers: 20991
First Submitted: April 2, 2013
First Posted: April 9, 2013
Results First Submitted: September 22, 2016
Results First Posted: November 11, 2016
Last Update Posted: January 2, 2017