Trial Outcomes & Findings for Effect of Oxytocin on Stress in Marijuana Users (NCT NCT01335789)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

5 minutes following Trier Social Stress Task completion

Results posted on

2015-12-14

Participant Flow

Participants recruited between and March 2011 and August 2011 through community advertisements.

Participant milestones

Participant milestones
Measure	Oxytocin intranasal administration Oxytocin: 40 IUs	Saline intranasal administration Saline: 40 IUs
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Oxytocin on Stress in Marijuana Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=8 Participants intranasal administration Oxytocin: 40 IUs	Saline n=8 Participants intranasal administration Saline: 40 IUs	Total n=16 Participants Total of all reporting groups
Age, Continuous	23.7 years STANDARD_DEVIATION 6.3 • n=5 Participants	22.9 years STANDARD_DEVIATION 7.1 • n=7 Participants	23.3 years STANDARD_DEVIATION 6.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes following Trier Social Stress Task completion

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=8 Participants intranasal administration Oxytocin: 40 IUs	Saline n=8 Participants intranasal administration Saline: 40 IUs
Stress (as Measured by Cortisol)	1.8 nmol/L Interval 1.5 to 2.2	2.1 nmol/L Interval 1.7 to 2.4

PRIMARY outcome

Timeframe: 5 minutes following Trier Social Stress Task completion

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=8 Participants intranasal administration Oxytocin: 40 IUs	Saline n=8 Participants intranasal administration Saline: 40 IUs
Stress (as Measured by Subjective Report)	2.4 units on a scale Interval 0.2 to 4.6	3.0 units on a scale Interval 0.8 to 5.2

SECONDARY outcome

Timeframe: 5 minutes following Trier Social Stress Task completion

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=8 Participants intranasal administration Oxytocin: 40 IUs	Saline n=8 Participants intranasal administration Saline: 40 IUs
Craving (as Measured by the Marijuana Craving Questionnaire)	41.1 units on a scale Interval 32.4 to 49.8	53.4 units on a scale Interval 44.7 to 62.1

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxytocin n=8 participants at risk intranasal administration Oxytocin: 40 IUs	Saline n=8 participants at risk intranasal administration Saline: 40 IUs
General disorders nasal irritation	0.00% 0/8	12.5% 1/8 • Number of events 1
Nervous system disorders headache	0.00% 0/8	25.0% 2/8 • Number of events 2
Psychiatric disorders irritability	12.5% 1/8 • Number of events 1	0.00% 0/8
General disorders unpleasant taste in mouth	12.5% 1/8 • Number of events 1	0.00% 0/8

Additional Information

Aimee McRae-Clark, Pharm.D., BCPP

Medical University of South Carolina

Phone: 843-792-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place