Trial · NCT03016598
Stimulant Oxytocin Study
NCT03016598, Phase 2, Completed, VA Office of Research and Development; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stimulant Oxytocin Study. Trials, record NCT03016598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03016598
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stimulant Oxytocin Study
- NCT number
- NCT03016598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Stimulant Use & Co-occuring Opioid Use Disorders
- Interventions
- Intranasal oxytocin, Intranasal placebo
- First posted
- 2017-01-10
- Last updated
- 2021-06-10
- Results first posted
- 2021-06-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Stimulant Positive Drug Screen | Baseline, Visits 1-7, up to 7 weeks | Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use. |
| Secondary | Working Alliance Inventory (WAI) | Visits 1 and 7, Up to 7 weeks | Aim 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. |
| Secondary | Heart Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 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. |
| Secondary | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 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. |
| Secondary | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 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. |
| Secondary | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 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. |
| Secondary | Self-reported Stimulant Craving | Visits 1 and 7, Up to 7 weeks | Aim 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. |
| Secondary | Individual and Group Therapy Attendance Rates | Visits 1-7, Up to 7 weeks | Aim 5: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by individual and group therapy attendance rates. |
| Secondary | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. |
| Secondary | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Visits 1 and 7, up to 7 weeks | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Stimulant Positive Drug Screen | Baseline, Visits 1-7, up to 7 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Working Alliance Inventory (WAI) | Visits 1 and 7, Up to 7 weeks | score on a scale | MEAN | |
| SECONDARY | Heart Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Beats/minute | MEAN | |
| SECONDARY | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Breaths/minute | MEAN | |
| SECONDARY | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | milliseconds squared | MEAN | |
| SECONDARY | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | milliseconds | MEAN | |
| SECONDARY | Self-reported Stimulant Craving | Visits 1 and 7, Up to 7 weeks | score on a scale | MEAN | |
| SECONDARY | Individual and Group Therapy Attendance Rates | Visits 1-7, Up to 7 weeks | proportion of OTP visits attended | MEAN | |
| SECONDARY | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | (ug/dL) | MEAN | |
| SECONDARY | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Visits 1 and 7, up to 7 weeks | (pg/mL) | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Stimulant Positive Drug Screen | Oxytocin | Stimulant Positive: Baseline | 9 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Placebo | Stimulant Positive: Baseline | 12 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Oxytocin | Stimulant Positive: Week 1 | 9 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Placebo | Stimulant Positive: Week 1 | 10 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Oxytocin | Stimulant Postive: Week 2 | 10 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Placebo | Stimulant Postive: Week 2 | 11 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Oxytocin | Stimulant Positive: Week 3 | 8 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Placebo | Stimulant Positive: Week 3 | 11 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Oxytocin | Stimulant Positive: Week 4 | 8 | Participants | |
| Number of Participants With Stimulant Positive Drug Screen | Placebo | Stimulant Positive: Week 4 | 12 | Participants |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxytocin | 18 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | Oxytocin | 18 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Oxytocin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Oxytocin | 1 | 18 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Stinging sensation | Skin and subcutaneous tissue disorders | Oxytocin | 1 | 18 | 1 |
| other | Stinging sensation | Skin and subcutaneous tissue disorders | Placebo | 0 | 22 | 0 |
| other | Hallucination | Psychiatric disorders | Oxytocin | 0 | 18 | 0 |
| other | Hallucination | Psychiatric disorders | Placebo | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxytocin | 0 | 18 |
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, other adverse events | Oxytocin | 1 | 18 |
| Total, other adverse events | Placebo | 1 | 22 |
| Total, serious adverse events | Oxytocin | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25295428 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| IK2CX001495 | 6-week trial of oxytocin for co-occurring cocaine and opioid use disorders | STAUFFER, CHRISTOPHER | PORTLAND VA MEDICAL CENTER | Veterans Affairs | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oxytocin vs Placebo: deaths from any cause | Trial comparisons |
| Oxytocin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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