Trial Outcomes & Findings for Effect of Oxytocin on Craving and Therapy Response (NCT NCT01827332)

NCT ID: NCT01827332

Last Updated: 2017-01-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit
• Results posted on: 2017-01-02

Participant Flow

Participants recruited between July 2014 and May 2015 primarily through media and internet advertisements.

Participant milestones

Measure	Oxytocin intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	Saline intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
Overall Study STARTED	8	8
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Oxytocin intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	Saline intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Effect of Oxytocin on Craving and Therapy Response

Baseline characteristics by cohort

Measure	Oxytocin n=8 Participants intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.	Saline n=8 Participants intranasal administration Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.	Total n=16 Participants Total of all reporting groups
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
Gender Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit

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.

Outcome measures

Measure	Oxytocin n=6 Participants intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	Saline n=7 Participants intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
Therapy Session Satisfaction (as Measured by Subjective Report)	9.8 units on a scale Standard Error 0.4	9.7 units on a scale Standard Error 0.3

SECONDARY outcome

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

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.

Outcome measures

Measure	Oxytocin n=6 Participants intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	Saline n=7 Participants intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )	-1.39 daily smoking sessions Standard Error 0.42	-0.22 daily smoking sessions Standard Error 0.44

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

Measure	Oxytocin n=8 participants at risk intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.	Saline n=8 participants at risk intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
General disorders Headache	0.00% 0/8	25.0% 2/8 • Number of events 2
Skin and subcutaneous tissue disorders Other	12.5% 1/8 • Number of events 1	0.00% 0/8

Additional Information

Aimee McRae-Clark

MUSC

Phone: 843-792-5216

Email: mcraeal@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place