Trial Outcomes & Findings for Stimulant Oxytocin Study (NCT NCT03016598)
NCT ID: NCT03016598
Last Updated: 2021-06-10
Results Overview
Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline, Visits 1-7, up to 7 weeks
Results posted on
2021-06-10
Participant Flow
84 individuals assessed for eligibility, of which 38 were excluded. 28 of the 38 excluded were ineligible - 6 were lost to follow up and 4 were uninterested. The remaining 46 participants completed baseline assessment, of which 4 were excluded - 2 being ineligible, 1 being lost to follow up and the final being uninterested. Left remaining were 42 enrolled participants.
42 individuals were enrolled, 2 of which were excluded due to being lost to follow up before being assigned to an arm.
Participant milestones
| Measure |
Placebo
Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
Intranasal placebo: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
|
Oxytocin
Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
Intranasal oxytocin: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
Intranasal placebo: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
|
Oxytocin
Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
Intranasal oxytocin: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Stimulant Oxytocin Study
Baseline characteristics by cohort
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=22 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Total
n=40 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
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
53.94444 years
STANDARD_DEVIATION 11.35767 • n=5 Participants
|
63.13636 years
STANDARD_DEVIATION 7.265676 • n=7 Participants
|
59 years
STANDARD_DEVIATION 10.30061 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visits 1-7, up to 7 weeksAim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Baseline
|
9 Participants
|
12 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 1
|
9 Participants
|
10 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Postive: Week 2
|
10 Participants
|
11 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 3
|
8 Participants
|
11 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 4
|
8 Participants
|
12 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 5
|
9 Participants
|
12 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 6
|
9 Participants
|
11 Participants
|
|
Number of Participants With Stimulant Positive Drug Screen
Stimulant Positive: Week 7
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Visits 1 and 7, Up to 7 weeksAim 2: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by the Working Alliance Inventory, an inventory of therapeutic alliance. The Working Alliance Inventory is a 36 question inventory. Each item is scored from 1-7, minimum = 1 and maximum = 7. Minimum total score = 36 to maximum total score = 252. Higher scores represent higher satisfaction.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Working Alliance Inventory (WAI)
WAI Week 1: Self-Report
|
3.5972 score on a scale
Standard Deviation 0.8816
|
3.8182 score on a scale
Standard Deviation 0.8107
|
|
Working Alliance Inventory (WAI)
WAI Week 7: Self-Report
|
3.4676 score on a scale
Standard Deviation 0.785
|
3.5208 score on a scale
Standard Deviation 1.0516
|
|
Working Alliance Inventory (WAI)
WAI Week 1:Therapist
|
4.088 score on a scale
Standard Deviation 0.7048
|
3.754 score on a scale
Standard Deviation 0.7370
|
|
Working Alliance Inventory (WAI)
WAI Week 7: Therapist
|
4.1450 score on a scale
Standard Deviation 0.7334
|
3.7486 score on a scale
Standard Deviation 0.8308
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Heart rate was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate Baseline: Week 1
|
77.252 Beats/minute
Standard Deviation 8.34820
|
68.1912 Beats/minute
Standard Deviation 13.9445
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Speech Prep: Week 1
|
77.5306 Beats/minute
Standard Deviation 11.1108
|
69.8634 Beats/minute
Standard Deviation 13.2503
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Speech: Week 1
|
85.3146 Beats/minute
Standard Deviation 12.1203
|
79.4769 Beats/minute
Standard Deviation 15.1165
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Arithmetic: Week 1
|
85.1227 Beats/minute
Standard Deviation 10.65619
|
77.8194 Beats/minute
Standard Deviation 15.6546
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate Cooldown: Week 1
|
72.0023 Beats/minute
Standard Deviation 18.7152
|
68.8551 Beats/minute
Standard Deviation 12.1091
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate Baseline: Week 7
|
76.116 Beats/minute
Standard Deviation 8.7493
|
72.6821 Beats/minute
Standard Deviation 11.9550
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Speech Prep: Week 7
|
74.9320 Beats/minute
Standard Deviation 8.4512
|
69.9714 Beats/minute
Standard Deviation 12.1507
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Speech: Week 7
|
81.8189 Beats/minute
Standard Deviation 8.1597
|
79.2512 Beats/minute
Standard Deviation 14.2214
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate During Arithmetic: Week 7
|
82.6265 Beats/minute
Standard Deviation 8.4639
|
82.8517 Beats/minute
Standard Deviation 18.0291
|
|
Heart Rate in Response to Trier Social Stress Test (TSST).
Heart Rate Cooldown: Week 7
|
74.9591 Beats/minute
Standard Deviation 9.8852
|
68.8543 Beats/minute
Standard Deviation 11.8623
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Respiratory rate was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate Baseline: Week 1
|
10.9117 Breaths/minute
Standard Deviation 1.5119
|
11.2000 Breaths/minute
Standard Deviation 2.9642
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Speech Prep: Week 1
|
11.0512 Breaths/minute
Standard Deviation 3.3724
|
12.292 Breaths/minute
Standard Deviation 2.9966
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Speech: Week 1
|
11.4533 Breaths/minute
Standard Deviation 2.976
|
12.3352 Breaths/minute
Standard Deviation 2.9521
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Arithmetic: Week 1
|
10.56 Breaths/minute
Standard Deviation 1.7841
|
11.7565 Breaths/minute
Standard Deviation 3.5337
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate Cooldown: Week 1
|
10.6278 Breaths/minute
Standard Deviation 3.0036
|
10.5266 Breaths/minute
Standard Deviation 2.1028
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate Baseline: Week 7
|
11.6779 Breaths/minute
Standard Deviation 3.795
|
11.4583 Breaths/minute
Standard Deviation 2.3595
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Speech Prep: Week 7
|
10.6251 Breaths/minute
Standard Deviation 1.8414
|
12.7914 Breaths/minute
Standard Deviation 3.7546
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Speech: Week 7
|
10.6675 Breaths/minute
Standard Deviation 3.0857
|
11.5526 Breaths/minute
Standard Deviation 3.304
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate During Arithmetic: Week 7
|
10.4215 Breaths/minute
Standard Deviation 1.9839
|
12.4459 Breaths/minute
Standard Deviation 2.4201
|
|
Respiratory Rate in Response to Trier Social Stress Test (TSST).
Respiratory Rate Cooldown: Week 7
|
9.9913 Breaths/minute
Standard Deviation 2.6662
|
10.3816 Breaths/minute
Standard Deviation 2.9001
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Respiratory sinus arrythmia (RSA) was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Baseline: Week 1
|
4.2435 milliseconds squared
Standard Deviation 1.2701
|
4.9543 milliseconds squared
Standard Deviation 1.8461
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Speech Prep: Week 1
|
4.6264 milliseconds squared
Standard Deviation 1.2903
|
4.7393 milliseconds squared
Standard Deviation 1.5292
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Speech: Week 1
|
3.5542 milliseconds squared
Standard Deviation 1.2285
|
3.8212 milliseconds squared
Standard Deviation 1.3293
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Arithmetic: Week 1
|
3.5364 milliseconds squared
Standard Deviation 1.1521
|
3.7893 milliseconds squared
Standard Deviation 1.1818
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Cooldown: Week1
|
4.3466 milliseconds squared
Standard Deviation 1.0783
|
4.4933 milliseconds squared
Standard Deviation 1.3137
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Baseline: Week 7
|
4.1866 milliseconds squared
Standard Deviation 1.1912
|
4.053 milliseconds squared
Standard Deviation 1.7715
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Speech Prep: Week 7
|
4.0099 milliseconds squared
Standard Deviation 1.3911
|
4.2972 milliseconds squared
Standard Deviation 1.6850
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Speech: Week 7
|
3.6254 milliseconds squared
Standard Deviation 1.3660
|
3.5998 milliseconds squared
Standard Deviation 1.523
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Arithmetic: Week 7
|
3.4825 milliseconds squared
Standard Deviation 1.3147
|
3.5267 milliseconds squared
Standard Deviation 1.3283
|
|
Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Respiratory Sinus Arrythmia During Cooldown: Week 7
|
3.9752 milliseconds squared
Standard Deviation 1.4793
|
4.1651 milliseconds squared
Standard Deviation 1.5196
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. The root mean square of successive differences (RMSSD) were assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels. Calculated by measuring each successive time difference between heartbeats in ms.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Baseline: Week 1
|
26.8196 milliseconds
Standard Deviation 41.5701
|
48.865 milliseconds
Standard Deviation 48.2147
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Speech Prep: Week 1
|
28.5447 milliseconds
Standard Deviation 38.5287
|
37.7607 milliseconds
Standard Deviation 44.6989
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Speech: Week 1
|
22.5526 milliseconds
Standard Deviation 44.3238
|
20.9388 milliseconds
Standard Deviation 21.2336
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Arithmetic: Week 1
|
21.113 milliseconds
Standard Deviation 39.3470
|
21.1729 milliseconds
Standard Deviation 18.4126
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Cooldown: Week 1
|
29.7325 milliseconds
Standard Deviation 53.4858
|
34.5220 milliseconds
Standard Deviation 43.9497
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Baseline Week 7
|
15.7941 milliseconds
Standard Deviation 9.0513
|
26.3299 milliseconds
Standard Deviation 30.7912
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Speech Prep: Week 7
|
16.0198 milliseconds
Standard Deviation 9.2258
|
28.1708 milliseconds
Standard Deviation 31.7601
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Speech: Week 7
|
12.9299 milliseconds
Standard Deviation 7.5432
|
22.1121 milliseconds
Standard Deviation 30.6961
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Arithmetic: Week 7
|
11.3174 milliseconds
Standard Deviation 6.5779
|
21.2057 milliseconds
Standard Deviation 32.3207
|
|
Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
RMSSD During Cooldown: Week 7
|
17.9728 milliseconds
Standard Deviation 13.0228
|
24.6587 milliseconds
Standard Deviation 20.8481
|
SECONDARY outcome
Timeframe: Visits 1 and 7, Up to 7 weeksAim 4: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant craving in response the Trier Social Stress Test (TSST). The Cocaine Craving Questionnaire (CCQ) (brief) was modified to include all stimulants and administered. The CCQ is a 10-item questionnaire, with each item ranking on a scale of 1-7. 1 indicates 'Strongly Disagree' and 7 indicates 'Strongly Agree'. Higher scores indicate higher rates of craving. The CCQ was administered at three distinct time points: before the TSST, immediately after the TSST and 20 minutes post-TSST. The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Self-reported Stimulant Craving
Pre_Trier: Week 1
|
2.1667 score on a scale
Standard Deviation 1.1827
|
1.82727 score on a scale
Standard Deviation 1.1707
|
|
Self-reported Stimulant Craving
Imm_Post_Trier: Week 1
|
2.4389 score on a scale
Standard Deviation 1.7446
|
2.35 score on a scale
Standard Deviation 1.6964
|
|
Self-reported Stimulant Craving
20m_Post_Trier: Week 1
|
2.3056 score on a scale
Standard Deviation 1.4941
|
1.8955 score on a scale
Standard Deviation 1.2688
|
|
Self-reported Stimulant Craving
Pre_Trier: Week 7
|
1.7167 score on a scale
Standard Deviation 1.0755
|
1.42 score on a scale
Standard Deviation 0.7135
|
|
Self-reported Stimulant Craving
Imm_Post_Trier: Week 7
|
1.6833 score on a scale
Standard Deviation 0.8535
|
1.48 score on a scale
Standard Deviation 0.818
|
|
Self-reported Stimulant Craving
20m_Post_Trier: Week 7
|
1.7167 score on a scale
Standard Deviation 1.058
|
1.67 score on a scale
Standard Deviation 1.0255
|
SECONDARY outcome
Timeframe: Visits 1-7, Up to 7 weeksAim 5: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by individual and group therapy attendance rates.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 1
|
0.9352 proportion of OTP visits attended
Standard Deviation 0.1416
|
0.8406 proportion of OTP visits attended
Standard Deviation 0.3047
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 2
|
0.9333 proportion of OTP visits attended
Standard Deviation 0.1183
|
0.8485 proportion of OTP visits attended
Standard Deviation 0.2951
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 3
|
0.9241 proportion of OTP visits attended
Standard Deviation 0.1652
|
0.8429 proportion of OTP visits attended
Standard Deviation 0.3022
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 4
|
0.9260 proportion of OTP visits attended
Standard Deviation 0.1828
|
0.7857 proportion of OTP visits attended
Standard Deviation 0.3580
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 5
|
0.8704 proportion of OTP visits attended
Standard Deviation 0.2181
|
0.7476 proportion of OTP visits attended
Standard Deviation 0.3572
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 6
|
0.9444 proportion of OTP visits attended
Standard Deviation 0.1560
|
0.7483 proportion of OTP visits attended
Standard Deviation 0.3915
|
|
Individual and Group Therapy Attendance Rates
Attendance Proportion: Week 7
|
1 proportion of OTP visits attended
Standard Deviation 0
|
0.75 proportion of OTP visits attended
Standard Deviation 0.4443
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Initial Cortisol Levels (ug/dL) Week 1
|
0.331 (ug/dL)
Standard Deviation 0.263
|
0.319 (ug/dL)
Standard Deviation 0.335
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Pre-Trier Cortisol Levels (ug/dL) Week 1
|
0.283 (ug/dL)
Standard Deviation 0.213
|
0.193 (ug/dL)
Standard Deviation 0.163
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Immediately Post-Trier Cortisol Levels (ug/dL) Week 1
|
0.286 (ug/dL)
Standard Deviation 0.221
|
0.242 (ug/dL)
Standard Deviation 0.286
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
20Minutes Post-Trier Cortisol Levels (ug/dL) Week 1
|
0.29 (ug/dL)
Standard Deviation 0.184
|
0.211 (ug/dL)
Standard Deviation 0.245
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Initial Cortisol Levels (ug/dL) Week 7
|
0.206 (ug/dL)
Standard Deviation 0.155
|
0.259 (ug/dL)
Standard Deviation 0.154
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Pre-Trier Cortisol Levels (ug/dL) Week 7
|
0.156 (ug/dL)
Standard Deviation 0.093
|
0.197 (ug/dL)
Standard Deviation 0.115
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
Immediately Post-Trier Cortisol Levels (ug/dL) Week 7
|
0.167 (ug/dL)
Standard Deviation 0.112
|
0.184 (ug/dL)
Standard Deviation 0.09
|
|
Cortisol Levels in Response to Trier Social Stress Test (TSST).
20 Minutes Post-Trier Cortisol Levels (ug/dL) Week 7
|
0.175 (ug/dL)
Standard Deviation 0.130
|
0.168 (ug/dL)
Standard Deviation 0.073
|
SECONDARY outcome
Timeframe: Visits 1 and 7, up to 7 weeksAim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Initial DHEA Levels (pg/mL) Week 1
|
86.230 (pg/mL)
Standard Deviation 52.999
|
62.695 (pg/mL)
Standard Deviation 67.462
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Pre-Trier DHEA Levels (pg/mL) Week 1
|
90.313 (pg/mL)
Standard Deviation 80.944
|
52.32 (pg/mL)
Standard Deviation 55.91
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Immediately Post-Trier DHEA Levels (pg/mL) Week 1
|
100.468 (pg/mL)
Standard Deviation 76.830
|
63.471 (pg/mL)
Standard Deviation 57.251
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
20 Minutes Post-Trier DHEA Levels (pg/mL) Week 1
|
81.742 (pg/mL)
Standard Deviation 68.051
|
54.816 (pg/mL)
Standard Deviation 52.980
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Initial DHEA Levels(pg/mL) Week 7
|
87.674 (pg/mL)
Standard Deviation 78.363
|
61.581 (pg/mL)
Standard Deviation 77.382
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Pre-Trier DHEA Levels (pg/mL) Week 7
|
75.221 (pg/mL)
Standard Deviation 80.167
|
54.324 (pg/mL)
Standard Deviation 57.183
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Immediately Post-Trier DHEA Levels (pg/mL) Week 7
|
84.230 (pg/mL)
Standard Deviation 72.875
|
69.291 (pg/mL)
Standard Deviation 108.134
|
|
Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
20 Minutes Post-Trier DHEA Levels (pg/mL) Week 7
|
82.009 (pg/mL)
Standard Deviation 86.669
|
66.736 (pg/mL)
Standard Deviation 103.362
|
SECONDARY outcome
Timeframe: Visits 1 and 7, Up to 7 weeksAim 7: To evaluate the effectiveness of intranasal oxytocin on reducing self-reported stress/anxiety levels in response to the TSST. The scale used to measure anxiety was the State-Trait Anxiety Inventory (STAI-6). This scale consists of 40 questions, all of which are rated on a 4-point likert scale. 1 indicates 'Almost Never' while 4 indicates 'Almost Always'. The minimum score is 0, indicating no anxiety, and maximum score is 63, indicating severe anxiety.
Outcome measures
| Measure |
Oxytocin
n=18 Participants
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=20 Participants
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Self-reported Stress/Anxiety
Pre_Trier: Week 1
|
34.815 score on a scale
Standard Deviation 13.778
|
32.2727 score on a scale
Standard Deviation 11.0978
|
|
Self-reported Stress/Anxiety
Imm_Post_Trier: Week 1
|
46.4815 score on a scale
Standard Deviation 15.529
|
46.0606 score on a scale
Standard Deviation 19.29
|
|
Self-reported Stress/Anxiety
20m_Post_Trier: Week 1
|
36.8519 score on a scale
Standard Deviation 14.4834
|
36.97 score on a scale
Standard Deviation 14.5809
|
|
Self-reported Stress/Anxiety
Pre_Trier: Week 7
|
35.185 score on a scale
Standard Deviation 12.379
|
29.17 score on a scale
Standard Deviation 11.38
|
|
Self-reported Stress/Anxiety
Imm_Post_Trier: Week 7
|
42.222 score on a scale
Standard Deviation 15.966
|
36.5 score on a scale
Standard Deviation 11.7217
|
|
Self-reported Stress/Anxiety
20m_Post_Trier: Week 7
|
35.741 score on a scale
Standard Deviation 11.871
|
31 score on a scale
Standard Deviation 11.726
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=18 participants at risk
Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
Placebo
n=22 participants at risk
Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 2 • 18 months
|
0.00%
0/22 • 18 months
|
|
Skin and subcutaneous tissue disorders
Stinging sensation
|
5.6%
1/18 • Number of events 1 • 18 months
|
0.00%
0/22 • 18 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/18 • 18 months
|
4.5%
1/22 • Number of events 1 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place