Trial Outcomes & Findings for Oxytocin Treatment of Alcohol Dependence (NCT NCT02275611)

Last Updated: 2017-04-04

Results Overview

The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments

Results posted on

2017-04-04

Participant Flow

The numbers of subjects recruited into the withdrawal study alone, outpatient study alone, or both = 13. Some people dropped out of the inpatient withdrawal phase after they completed that phase. Additional participants were added for the second, outpatient phase.

Participant milestones

Participant milestones
Measure	Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray) Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks. Inpatient Withdrawal	Placebo Comparator: Intranasal Placebo Spray Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal	Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon) 2 daily doses intranasal oxytocin spray for 12 weeks	Outpatient Treatment Placebo Spray 2 daily doses intranasal placebo spray for 12 weeks
Inpatient Withdrawal STARTED	5	4	0	0
Inpatient Withdrawal COMPLETED	4	4	0	0
Inpatient Withdrawal NOT COMPLETED	1	0	0	0
Outpatient Drinking STARTED	0	0	6	3
Outpatient Drinking COMPLETED	0	0	6	3
Outpatient Drinking NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray) Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks. Inpatient Withdrawal	Placebo Comparator: Intranasal Placebo Spray Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal	Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon) 2 daily doses intranasal oxytocin spray for 12 weeks	Outpatient Treatment Placebo Spray 2 daily doses intranasal placebo spray for 12 weeks
Inpatient Withdrawal Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Only 4 oxytocin recipients and 4 placebo recipients were involved in the study of intranasal treatments on alcohol withdrawal as determined by CIWA scores

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Oxytocin Spray (Syntocinon) n=5 Participants Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal	Intranasal Placebo Spray n=4 Participants Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal	Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon) n=8 Participants 2 daily doses intranasal oxytocin spray for 12 weeks	Outpatient Treatment Placebo Spray n=5 Participants 2 daily doses intranasal placebo spray for 12 weeks	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants	5 Participants n=5 Participants	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=8 Participants	2 Participants n=5 Participants	8 Participants n=22 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=8 Participants	3 Participants n=5 Participants	14 Participants n=22 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants	5 Participants n=5 Participants	22 Participants n=22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=8 Participants	2 Participants n=5 Participants	7 Participants n=22 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants	3 Participants n=5 Participants	15 Participants n=22 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=22 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=4 Participants	6 participants n=8 Participants	3 participants n=5 Participants	9 participants n=22 Participants
Clinical Institute Withdrawal Assessment for Alcohol (CIWA)	6.41 scores on a scale STANDARD_DEVIATION 1.45 • n=4 Participants • Only 4 oxytocin recipients and 4 placebo recipients were involved in the study of intranasal treatments on alcohol withdrawal as determined by CIWA scores	5.57 scores on a scale STANDARD_DEVIATION 1.85 • n=4 Participants • Only 4 oxytocin recipients and 4 placebo recipients were involved in the study of intranasal treatments on alcohol withdrawal as determined by CIWA scores	—	—	5.99 scores on a scale STANDARD_DEVIATION 1.60 • n=8 Participants • Only 4 oxytocin recipients and 4 placebo recipients were involved in the study of intranasal treatments on alcohol withdrawal as determined by CIWA scores

PRIMARY outcome

Timeframe: Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments

Population: This assessment was done only in the inpatient withdrawal phase.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin Spray (Syntocinon Spray) n=4 Participants Syntocinon Spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray	Intranasal Placebo Spray n=4 Participants Placebo spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray Intranasal Placebo Spray: Intranasal Placebo Spray
Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score	-2.76 units on a scale Standard Deviation 1.95	1.01 units on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: 48 hours after initiation of intranasal test doses

Population: This assessment was done only in the inpatient withdrawal phase.

Cumulative lorazepam received (2 mg doses) After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were \>7, diastolic blood pressure rose to \>120, or heart rate rose to \>110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin Spray (Syntocinon Spray) n=4 Participants Syntocinon Spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray	Intranasal Placebo Spray n=4 Participants Placebo spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray Intranasal Placebo Spray: Intranasal Placebo Spray
Total mg of Lorazepam for Detoxification	2.25 cumulative lorazepam doses (mg) Standard Deviation 1.26	5.25 cumulative lorazepam doses (mg) Standard Deviation 2.5

SECONDARY outcome

Timeframe: 90 days prior to admission and 4 weeks in the outpatient setting

Population: This assessment was done only in the outpatient phase.

A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.

Outcome measures

Outcome measures
Measure	Intranasal Oxytocin Spray (Syntocinon Spray) n=6 Participants Syntocinon Spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray	Intranasal Placebo Spray n=3 Participants Placebo spray 3-4 doses daily inpatient intranasal oxytocin spray: Administration of oxytocin in a nasal spray Intranasal Placebo Spray: Intranasal Placebo Spray
Change in Percentage Heavy Drinking Days	-0.377 percentage of heavy drinking days change Standard Deviation 0.28	-0.972 percentage of heavy drinking days change Standard Deviation 0.032

Adverse Events

Intranasal Oxytocin Spray (Syntocinon Spray)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intranasal Placebo Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Outpatient Treatment Placebo Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cort A. Pedersen

University of North Carolina at Chapel Hill

Phone: (919) 966-4447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place