MedDataX Logo

Trial Outcomes & Findings for Oxytocin Treatment of Opioid Dependence (NCT NCT02548728)

NCT ID: NCT02548728

Last Updated: 2019-08-07

Results Overview

The Clinical Opiate Withdrawal Scale (COWS) is an 11-item, observer-rated tool for quantifying withdrawal symptoms. Each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). Lower scores are more favorable.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.

Results posted on

2019-08-07

Participant Flow

Participant milestones

Participant milestones
Measure
Oxytocin
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
Overall Study
STARTED
6
6
Overall Study
COMPLETED
6
6
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxytocin Treatment of Opioid Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Oxytocin
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
Total
n=12 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
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 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
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Region of Enrollment
United States
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.

The Clinical Opiate Withdrawal Scale (COWS) is an 11-item, observer-rated tool for quantifying withdrawal symptoms. Each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). Lower scores are more favorable.

Outcome measures

Outcome measures
Measure
Oxytocin
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive
4.2 Average COWS score * hours
Standard Error 1.5
3.4 Average COWS score * hours
Standard Error 1.5

SECONDARY outcome

Timeframe: 5 days

Population: SOWS data not collected due to subject noncompliance in adhering to form completion.

Least squares mean AUC day 1 pre-dose through Day 5 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1-5, the AUC includes data starting from time 0 hours up to 120 hours post-dose.

Craving levels were measured using the VAS score on Days 1 to 5; the VAS scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had"). Note that the value of AUC is a product of time multiplied by VAS scale score thus the numeric values are higher than the highest value on the scale.

Outcome measures

Outcome measures
Measure
Oxytocin
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
n=6 Participants
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive
1498 Average VAS score * hours
Standard Deviation 839
2037 Average VAS score * hours
Standard Deviation 2253

SECONDARY outcome

Timeframe: Daily up to 5 days

Population: STAI data not collected due to subject noncompliance in adhering to form completion.

The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

Outcome measures

Outcome data not reported

Adverse Events

Oxytocin

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Oxytocin
n=6 participants at risk
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
n=6 participants at risk
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
Psychiatric disorders
Psychosis
16.7%
1/6
0.00%
0/6

Other adverse events

Other adverse events
Measure
Oxytocin
n=6 participants at risk
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
Placebo
n=6 participants at risk
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
Psychiatric disorders
Insomnia
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Aching
33.3%
2/6 • Number of events 2
33.3%
2/6 • Number of events 2
Nervous system disorders
Chills
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Abdominal cramps
33.3%
2/6 • Number of events 2
33.3%
2/6 • Number of events 2
Psychiatric disorders
Restlessnes
16.7%
1/6 • Number of events 1
0.00%
0/6
Psychiatric disorders
Anxiety
50.0%
3/6 • Number of events 3
66.7%
4/6 • Number of events 4
General disorders
Sweats
16.7%
1/6 • Number of events 1
0.00%
0/6
Nervous system disorders
Tremor
0.00%
0/6
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Diarrhea
16.7%
1/6 • Number of events 1
0.00%
0/6
Gastrointestinal disorders
Nausea
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Constipation
0.00%
0/6
16.7%
1/6 • Number of events 1
Nervous system disorders
Restless legs
16.7%
1/6 • Number of events 1
0.00%
0/6

Additional Information

Cort Pedersen, MD

University of North Carolina at Chapel Hill

Phone: 919-923-3284

Results disclosure agreements

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