Trial Outcomes & Findings for Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals (NCT NCT01963091)
NCT ID: NCT01963091
Last Updated: 2018-06-04
Results Overview
salivary cortisol
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
0 minutes post 15 minute stress task
Results posted on
2018-06-04
Participant Flow
Participant milestones
| Measure |
Oxytocin
oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Placebo
saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
Baseline characteristics by cohort
| Measure |
Oxytocin
n=17 Participants
oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Placebo
n=16 Participants
saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Total
n=33 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
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 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
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 minutes post 15 minute stress tasksalivary cortisol
Outcome measures
| Measure |
Oxytocin
n=17 Participants
oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Placebo
n=16 Participants
saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
|---|---|---|
|
Salivary Cortisol Levels
|
0.18 mg/dl
Standard Deviation 0.09
|
0.22 mg/dl
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 0 minutes post 15 minute stress taskSubjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
Outcome measures
| Measure |
Oxytocin
n=17 Participants
oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Placebo
n=16 Participants
saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
|---|---|---|
|
Likert Scale Rating of Subjective Stress
|
4.18 units on a scale
Standard Deviation 3.49
|
4.25 units on a scale
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: 0 mintues post 15 minute stress taskSubjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
Outcome measures
| Measure |
Oxytocin
n=17 Participants
oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
Placebo
n=16 Participants
saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
|---|---|---|
|
Likert Scale Rating of Subjective Craving
|
3.35 units on a scale
Standard Deviation 4.03
|
3.13 units on a scale
Standard Deviation 2.80
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place