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Effect of Oxytocin on Stress in Marijuana Users

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ClinicalTrials.gov Identifier: NCT01335789
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : August 15, 2014
Last Update Posted : December 14, 2015
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 and March 2011 and August 2011 through community advertisements.
Pre-assignment Details  
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

Period Title: Overall Study
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Oxytocin Saline Total
Hide Arm/Group Description

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
23.7  (6.3) 22.9  (7.1) 23.3  (6.5)
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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
1
  12.5%
3
  37.5%
4
  25.0%
Male
7
  87.5%
5
  62.5%
12
  75.0%
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 Stress (as Measured by Cortisol)
Hide Description Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame 5 minutes following Trier Social Stress Task completion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

Overall Number of Participants Analyzed 8 8
Mean (95% Confidence Interval)
Unit of Measure: nmol/L
1.8
(1.5 to 2.2)
2.1
(1.7 to 2.4)
2.Primary Outcome
Title Stress (as Measured by Subjective Report)
Hide Description Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame 5 minutes following Trier Social Stress Task completion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

Overall Number of Participants Analyzed 8 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.4
(0.2 to 4.6)
3.0
(0.8 to 5.2)
3.Secondary Outcome
Title Craving (as Measured by the Marijuana Craving Questionnaire)
Hide Description The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1–7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame 5 minutes following Trier Social Stress Task completion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

Overall Number of Participants Analyzed 8 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
41.1
(32.4 to 49.8)
53.4
(44.7 to 62.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

intranasal administration

Oxytocin: 40 IUs

intranasal administration

Saline: 40 IUs

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     
nasal irritation  0/8 (0.00%)  0 1/8 (12.50%)  1
unpleasant taste in mouth  1/8 (12.50%)  1 0/8 (0.00%)  0
Nervous system disorders     
headache  0/8 (0.00%)  0 2/8 (25.00%)  2
Psychiatric disorders     
irritability  1/8 (12.50%)  1 0/8 (0.00%)  0
Small sample size, non-treatment seeking sample, predominantly male sample
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Aimee McRae-Clark, Pharm.D., BCPP
Organization: Medical University of South Carolina
Phone: 843-792-5216
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01335789     History of Changes
Other Study ID Numbers: 20274
First Submitted: April 8, 2011
First Posted: April 14, 2011
Results First Submitted: June 2, 2014
Results First Posted: August 15, 2014
Last Update Posted: December 14, 2015