Who is sponsoring NCT03016598?

NCT03016598 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT03016598?

Interventions in NCT03016598: Intranasal oxytocin, Intranasal placebo.

What condition does NCT03016598 study?

NCT03016598 studies Stimulant Use & Co-occuring Opioid Use Disorders.

Is NCT03016598 still recruiting?

NCT03016598 is currently completed. Last updated 10 June 2021.

Are results published for NCT03016598?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-10 · How we verify

NCT03016598: SOS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stimulant Oxytocin Study

Completed Phase 2 Results posted Last updated 10 June 2021

What this trial tests

Phase 2 trial testing Intranasal oxytocin in Stimulant Use & Co-occuring Opioid Use Disorders in 42 participants. Completed in 14 February 2020.

Timeline

26 January 2018

Primary endpoint
14 February 2020

14 February 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	26 January 2018
Primary completion	14 February 2020
Estimated completion	14 February 2020
Sites	3 locations across United States

Drugs / interventions tested

Intranasal oxytocin — full drug profile →
Intranasal placebo — full drug profile →

Conditions studied

Stimulant Use & Co-occuring Opioid Use Disorders — all drugs for Stimulant Use & Co-occuring Opioid Use Disorders →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Stimulant Use & Co-occuring Opioid Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Stimulant Positive Drug Screen Primary · Baseline, Visits 1-7, up to 7 weeks

Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.

Stimulant Positive: Baseline

Group	Value	95% CI
Oxytocin	9
Placebo	12

Stimulant Positive: Week 1

Group	Value	95% CI
Oxytocin	9
Placebo	10

Stimulant Postive: Week 2

Group	Value	95% CI
Oxytocin	10
Placebo	11

Stimulant Positive: Week 3

Group	Value	95% CI
Oxytocin	8
Placebo	11

Stimulant Positive: Week 4

Group	Value	95% CI
Oxytocin	8
Placebo	12

Stimulant Positive: Week 5

Group	Value	95% CI
Oxytocin	9
Placebo	12

Stimulant Positive: Week 6

Group	Value	95% CI
Oxytocin	9
Placebo	11

Stimulant Positive: Week 7

Group	Value	95% CI
Oxytocin	9
Placebo	11

Working Alliance Inventory (WAI) Secondary · 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.

WAI Week 1: Self-Report

Group	Value	95% CI
Oxytocin	3.5972	± 0.8816
Placebo	3.8182	± 0.8107

WAI Week 7: Self-Report

Group	Value	95% CI
Oxytocin	3.4676	± 0.785
Placebo	3.5208	± 1.0516

WAI Week 1:Therapist

Group	Value	95% CI
Oxytocin	4.088	± 0.7048
Placebo	3.754	± 0.7370

WAI Week 7: Therapist

Group	Value	95% CI
Oxytocin	4.1450	± 0.7334
Placebo	3.7486	± 0.8308

Heart Rate in Response to Trier Social Stress Test (TSST). Secondary · 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

Heart Rate Baseline: Week 1

Group	Value	95% CI
Oxytocin	77.252	± 8.34820
Placebo	68.1912	± 13.9445

Heart Rate During Speech Prep: Week 1

Group	Value	95% CI
Oxytocin	77.5306	± 11.1108
Placebo	69.8634	± 13.2503

Heart Rate During Speech: Week 1

Group	Value	95% CI
Oxytocin	85.3146	± 12.1203
Placebo	79.4769	± 15.1165

Heart Rate During Arithmetic: Week 1

Group	Value	95% CI
Oxytocin	85.1227	± 10.65619
Placebo	77.8194	± 15.6546

Heart Rate Cooldown: Week 1

Group	Value	95% CI
Oxytocin	72.0023	± 18.7152
Placebo	68.8551	± 12.1091

Heart Rate Baseline: Week 7

Group	Value	95% CI
Oxytocin	76.116	± 8.7493
Placebo	72.6821	± 11.9550

Heart Rate During Speech Prep: Week 7

Group	Value	95% CI
Oxytocin	74.9320	± 8.4512
Placebo	69.9714	± 12.1507

Heart Rate During Speech: Week 7

Group	Value	95% CI
Oxytocin	81.8189	± 8.1597
Placebo	79.2512	± 14.2214

Respiratory Rate in Response to Trier Social Stress Test (TSST). Secondary · Visits 1 and 7, up to 7 weeks

Respiratory Rate Baseline: Week 1

Group	Value	95% CI
Oxytocin	10.9117	± 1.5119
Placebo	11.2000	± 2.9642

Respiratory Rate During Speech Prep: Week 1

Group	Value	95% CI
Oxytocin	11.0512	± 3.3724
Placebo	12.292	± 2.9966

Respiratory Rate During Speech: Week 1

Group	Value	95% CI
Oxytocin	11.4533	± 2.976
Placebo	12.3352	± 2.9521

Respiratory Rate During Arithmetic: Week 1

Group	Value	95% CI
Oxytocin	10.56	± 1.7841
Placebo	11.7565	± 3.5337

Respiratory Rate Cooldown: Week 1

Group	Value	95% CI
Oxytocin	10.6278	± 3.0036
Placebo	10.5266	± 2.1028

Respiratory Rate Baseline: Week 7

Group	Value	95% CI
Oxytocin	11.6779	± 3.795
Placebo	11.4583	± 2.3595

Respiratory Rate During Speech Prep: Week 7

Group	Value	95% CI
Oxytocin	10.6251	± 1.8414
Placebo	12.7914	± 3.7546

Respiratory Rate During Speech: Week 7

Group	Value	95% CI
Oxytocin	10.6675	± 3.0857
Placebo	11.5526	± 3.304

Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). Secondary · Visits 1 and 7, up to 7 weeks

Respiratory Sinus Arrythmia During Baseline: Week 1

Group	Value	95% CI
Oxytocin	4.2435	± 1.2701
Placebo	4.9543	± 1.8461

Respiratory Sinus Arrythmia During Speech Prep: Week 1

Group	Value	95% CI
Oxytocin	4.6264	± 1.2903
Placebo	4.7393	± 1.5292

Respiratory Sinus Arrythmia During Speech: Week 1

Group	Value	95% CI
Oxytocin	3.5542	± 1.2285
Placebo	3.8212	± 1.3293

Respiratory Sinus Arrythmia During Arithmetic: Week 1

Group	Value	95% CI
Oxytocin	3.5364	± 1.1521
Placebo	3.7893	± 1.1818

Respiratory Sinus Arrythmia During Cooldown: Week1

Group	Value	95% CI
Oxytocin	4.3466	± 1.0783
Placebo	4.4933	± 1.3137

Respiratory Sinus Arrythmia During Baseline: Week 7

Group	Value	95% CI
Oxytocin	4.1866	± 1.1912
Placebo	4.053	± 1.7715

Respiratory Sinus Arrythmia During Speech Prep: Week 7

Group	Value	95% CI
Oxytocin	4.0099	± 1.3911
Placebo	4.2972	± 1.6850

Respiratory Sinus Arrythmia During Speech: Week 7

Group	Value	95% CI
Oxytocin	3.6254	± 1.3660
Placebo	3.5998	± 1.523

Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). Secondary · Visits 1 and 7, up to 7 weeks

RMSSD During Baseline: Week 1

Group	Value	95% CI
Oxytocin	26.8196	± 41.5701
Placebo	48.865	± 48.2147

RMSSD During Speech Prep: Week 1

Group	Value	95% CI
Oxytocin	28.5447	± 38.5287
Placebo	37.7607	± 44.6989

RMSSD During Speech: Week 1

Group	Value	95% CI
Oxytocin	22.5526	± 44.3238
Placebo	20.9388	± 21.2336

RMSSD During Arithmetic: Week 1

Group	Value	95% CI
Oxytocin	21.113	± 39.3470
Placebo	21.1729	± 18.4126

RMSSD During Cooldown: Week 1

Group	Value	95% CI
Oxytocin	29.7325	± 53.4858
Placebo	34.5220	± 43.9497

RMSSD During Baseline Week 7

Group	Value	95% CI
Oxytocin	15.7941	± 9.0513
Placebo	26.3299	± 30.7912

RMSSD During Speech Prep: Week 7

Group	Value	95% CI
Oxytocin	16.0198	± 9.2258
Placebo	28.1708	± 31.7601

RMSSD During Speech: Week 7

Group	Value	95% CI
Oxytocin	12.9299	± 7.5432
Placebo	22.1121	± 30.6961

Self-reported Stimulant Craving Secondary · 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 se

Pre_Trier: Week 1

Group	Value	95% CI
Oxytocin	2.1667	± 1.1827
Placebo	1.82727	± 1.1707

Imm_Post_Trier: Week 1

Group	Value	95% CI
Oxytocin	2.4389	± 1.7446
Placebo	2.35	± 1.6964

20m_Post_Trier: Week 1

Group	Value	95% CI
Oxytocin	2.3056	± 1.4941
Placebo	1.8955	± 1.2688

Pre_Trier: Week 7

Group	Value	95% CI
Oxytocin	1.7167	± 1.0755
Placebo	1.42	± 0.7135

Imm_Post_Trier: Week 7

Group	Value	95% CI
Oxytocin	1.6833	± 0.8535
Placebo	1.48	± 0.818

20m_Post_Trier: Week 7

Group	Value	95% CI
Oxytocin	1.7167	± 1.058
Placebo	1.67	± 1.0255

Individual and Group Therapy Attendance Rates Secondary · 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.

Attendance Proportion: Week 1

Group	Value	95% CI
Oxytocin	0.9352	± 0.1416
Placebo	0.8406	± 0.3047

Attendance Proportion: Week 2

Group	Value	95% CI
Oxytocin	0.9333	± 0.1183
Placebo	0.8485	± 0.2951

Attendance Proportion: Week 3

Group	Value	95% CI
Oxytocin	0.9241	± 0.1652
Placebo	0.8429	± 0.3022

Attendance Proportion: Week 4

Group	Value	95% CI
Oxytocin	0.9260	± 0.1828
Placebo	0.7857	± 0.3580

Attendance Proportion: Week 5

Group	Value	95% CI
Oxytocin	0.8704	± 0.2181
Placebo	0.7476	± 0.3572

Attendance Proportion: Week 6

Group	Value	95% CI
Oxytocin	0.9444	± 0.1560
Placebo	0.7483	± 0.3915

Attendance Proportion: Week 7

Group	Value	95% CI
Oxytocin	1	± 0
Placebo	0.75	± 0.4443

Cortisol Levels in Response to Trier Social Stress Test (TSST). Secondary · 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.

Initial Cortisol Levels (ug/dL) Week 1

Group	Value	95% CI
Oxytocin	0.331	± 0.263
Placebo	0.319	± 0.335

Pre-Trier Cortisol Levels (ug/dL) Week 1

Group	Value	95% CI
Oxytocin	0.283	± 0.213
Placebo	0.193	± 0.163

Immediately Post-Trier Cortisol Levels (ug/dL) Week 1

Group	Value	95% CI
Oxytocin	0.286	± 0.221
Placebo	0.242	± 0.286

20Minutes Post-Trier Cortisol Levels (ug/dL) Week 1

Group	Value	95% CI
Oxytocin	0.29	± 0.184
Placebo	0.211	± 0.245

Initial Cortisol Levels (ug/dL) Week 7

Group	Value	95% CI
Oxytocin	0.206	± 0.155
Placebo	0.259	± 0.154

Pre-Trier Cortisol Levels (ug/dL) Week 7

Group	Value	95% CI
Oxytocin	0.156	± 0.093
Placebo	0.197	± 0.115

Immediately Post-Trier Cortisol Levels (ug/dL) Week 7

Group	Value	95% CI
Oxytocin	0.167	± 0.112
Placebo	0.184	± 0.09

20 Minutes Post-Trier Cortisol Levels (ug/dL) Week 7

Group	Value	95% CI
Oxytocin	0.175	± 0.130
Placebo	0.168	± 0.073

Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) Secondary · 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.

Initial DHEA Levels (pg/mL) Week 1

Group	Value	95% CI
Oxytocin	86.230	± 52.999
Placebo	62.695	± 67.462

Pre-Trier DHEA Levels (pg/mL) Week 1

Group	Value	95% CI
Oxytocin	90.313	± 80.944
Placebo	52.32	± 55.91

Immediately Post-Trier DHEA Levels (pg/mL) Week 1

Group	Value	95% CI
Oxytocin	100.468	± 76.830
Placebo	63.471	± 57.251

20 Minutes Post-Trier DHEA Levels (pg/mL) Week 1

Group	Value	95% CI
Oxytocin	81.742	± 68.051
Placebo	54.816	± 52.980

Initial DHEA Levels(pg/mL) Week 7

Group	Value	95% CI
Oxytocin	87.674	± 78.363
Placebo	61.581	± 77.382

Pre-Trier DHEA Levels (pg/mL) Week 7

Group	Value	95% CI
Oxytocin	75.221	± 80.167
Placebo	54.324	± 57.183

Immediately Post-Trier DHEA Levels (pg/mL) Week 7

Group	Value	95% CI
Oxytocin	84.230	± 72.875
Placebo	69.291	± 108.134

20 Minutes Post-Trier DHEA Levels (pg/mL) Week 7

Group	Value	95% CI
Oxytocin	82.009	± 86.669
Placebo	66.736	± 103.362

Self-reported Stress/Anxiety Secondary · Visits 1 and 7, Up to 7 weeks

Aim 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.

Pre_Trier: Week 1

Group	Value	95% CI
Oxytocin	34.815	± 13.778
Placebo	32.2727	± 11.0978

Imm_Post_Trier: Week 1

Group	Value	95% CI
Oxytocin	46.4815	± 15.529
Placebo	46.0606	± 19.29

20m_Post_Trier: Week 1

Group	Value	95% CI
Oxytocin	36.8519	± 14.4834
Placebo	36.97	± 14.5809

Pre_Trier: Week 7

Group	Value	95% CI
Oxytocin	35.185	± 12.379
Placebo	29.17	± 11.38

Imm_Post_Trier: Week 7

Group	Value	95% CI
Oxytocin	42.222	± 15.966
Placebo	36.5	± 11.7217

20m_Post_Trier: Week 7

Group	Value	95% CI
Oxytocin	35.741	± 11.871
Placebo	31	± 11.726

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxytocin

Serious: 0/18 (0%)

Deaths: 0/18

Placebo

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (3 terms — click to expand)

Reaction	System	Oxytocin	Placebo
Constipation	Gastrointestinal disorders	—	—
Stinging sensation	Skin and subcutaneous tissue disorders	—	—
Hallucination	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT03016598 adverse events section.

Sponsor's own description

This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Intranasal Oxytocin for Stimulant Use Disorder Among Male Veterans Enrolled in an Opioid Treatment Program: A Randomized Controlled Trial.
Stauffer CS, Samson S, Hickok A, Hoffman WF, et al · · 2021 · cited 5× · PMID 35111090 · DOI 10.3389/fpsyt.2021.804997

Verify or expand the search:

Other trials of Intranasal oxytocin

Trials testing the same drug.

NCT07053774 — Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain · Phase 2 · recruiting
NCT06405737 — Oxytocin's Effect on the Advantageous- and Disadvantageous-inequity · NA · completed
NCT05312008 — Does Oxytocin Alter Tolerance to or Motivation for Alcohol · Phase 2 · terminated
NCT05265806 — The Effects of Oxytocin Treatment on Social Touch · NA · completed
NCT05245708 — Effects of Oxytocin on Reinforcement Learning and Interoception · NA · completed

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03016598 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 10 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03016598.

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