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Trial Outcomes & Findings for Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients. (NCT NCT02255357)

NCT ID: NCT02255357

Last Updated: 2023-06-05

Results Overview

this is outcome for the phase 2, clinicial trial portion of this combined laboratory and clinical trial laboratory human study For the human laboratory study, Phase 1, the primary outcome is differences in ACTH levels following a) Intranasal Desmopressin, and, on a consecutive day, b) Intranasal Desmopressin preceded by a treatment with Intranasal Oxytocin (Syntocinon). this takes place on 2 consecutive days

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

43 participants

Primary outcome timeframe

Phase 1: 7 days; Phase 2: 6 weeks

Results posted on

2023-06-05

Participant Flow

For control participants, reasons for not being included in the final analysis included: 1) not completing the laboratory protocol (phase 1) the only portion of the study that they participated in. 2 did not complete, and 1 was excluded for medical complication during the laboratory challenge. For Cocaine use disorder patients, reasons for not included in the analysis or not counting as completers: 1) droping out after the initial inpatient laboratory phase;

Participant milestones

Participant milestones
Measure
Placebo
Solution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin.
Intranasal Syntocinon
Intranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Overall Study
STARTED
14
29
Overall Study
COMPLETED
4
5
Overall Study
NOT COMPLETED
10
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Solution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin.
Intranasal Syntocinon
Intranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Overall Study
Physician Decision
10
24

Baseline Characteristics

Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=14 Participants
Solution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin.
Intranasal Syntocinon
n=29 Participants
Intranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Total
n=43 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
14 Participants
n=5 Participants
29 Participants
n=7 Participants
43 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
3 Participants
n=5 Participants
10 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
19 Participants
n=7 Participants
30 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=5 Participants
27 Participants
n=7 Participants
40 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
29 participants
n=7 Participants
43 participants
n=5 Participants

PRIMARY outcome

Timeframe: Phase 1: 7 days; Phase 2: 6 weeks

this is outcome for the phase 2, clinicial trial portion of this combined laboratory and clinical trial laboratory human study For the human laboratory study, Phase 1, the primary outcome is differences in ACTH levels following a) Intranasal Desmopressin, and, on a consecutive day, b) Intranasal Desmopressin preceded by a treatment with Intranasal Oxytocin (Syntocinon). this takes place on 2 consecutive days

Outcome measures

Outcome measures
Measure
Placebo for Phase 2, Clinical Trial
n=14 Participants
Solution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin.
Intranasal Syntocinon for Clinical Trial Phase 2
n=29 Participants
Intranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Weeks of Abstinence From Cocaine
1.0 weeks
Interval 1.0 to 2.0
1.0 weeks
Interval 1.0 to 1.0

Adverse Events

Placebo

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

Intranasal Syntocinon

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

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=11 participants at risk
Solution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin.
Intranasal Syntocinon
n=15 participants at risk
Intranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
General disorders
feeling woozy
9.1%
1/11 • Number of events 1 • 6 months during randomized trial or participants length of participation
0.00%
0/15 • 6 months during randomized trial or participants length of participation
Gastrointestinal disorders
nausea
9.1%
1/11 • Number of events 1 • 6 months during randomized trial or participants length of participation
0.00%
0/15 • 6 months during randomized trial or participants length of participation
General disorders
headache
27.3%
3/11 • Number of events 3 • 6 months during randomized trial or participants length of participation
0.00%
0/15 • 6 months during randomized trial or participants length of participation
Respiratory, thoracic and mediastinal disorders
cough
9.1%
1/11 • Number of events 1 • 6 months during randomized trial or participants length of participation
0.00%
0/15 • 6 months during randomized trial or participants length of participation
General disorders
feeling energized
0.00%
0/11 • 6 months during randomized trial or participants length of participation
20.0%
3/15 • Number of events 3 • 6 months during randomized trial or participants length of participation
General disorders
less irritable
0.00%
0/11 • 6 months during randomized trial or participants length of participation
6.7%
1/15 • Number of events 1 • 6 months during randomized trial or participants length of participation
General disorders
calm
0.00%
0/11 • 6 months during randomized trial or participants length of participation
6.7%
1/15 • Number of events 1 • 6 months during randomized trial or participants length of participation

Additional Information

wilfrid raby, m.d.

new york psychiatric institute

Phone: 2129233031

Results disclosure agreements

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