Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Stimulant Oxytocin Study

Short name SOS

NCTNCT03016598 (opens ClinicalTrials.gov in a new tab)Other idNURA-014-16SOther id1IK2CX001495-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
42 participants (actual)
Sponsor
VA Office of Research and Development · Fed
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
26 Jan 2018
Primary completion
14 Feb 2020
Completion
14 Feb 2020
First posted
10 Jan 2017 (estimated)
Last update posted
10 Jun 2021
Conditions
Stimulant Use & Co-occuring Opioid Use Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 2

    SOS

    NCT03016598

    26 Jan 2018 to 14 Feb 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Intranasal oxytocinDrug
  • Intranasal placeboDrug

Arms2

  • Experimental

    Oxytocin

    Patients in methadone maintenance treatment (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 opioid use disorder (OUD) to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.

  • Placebo comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Stimulant Positive Drug Screen

    Time frame · Baseline, Visits 1-7, up to 7 weeks

    Registry description

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

Secondary outcomes(10)

  1. Working Alliance Inventory (WAI)

    Time frame · Visits 1 and 7, Up to 7 weeks

    Registry description

    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.

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

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    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.

  3. Respiratory Rate in Response to Trier Social Stress Test (TSST).

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    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.

  4. Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    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.

  5. Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    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.

  6. Self-reported Stimulant Craving

    Time frame · Visits 1 and 7, Up to 7 weeks

    Registry description

    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.

  7. Individual and Group Therapy Attendance Rates

    Time frame · Visits 1-7, Up to 7 weeks

    Registry description

    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.

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

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.

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

    Time frame · Visits 1 and 7, up to 7 weeks

    Registry description

    Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.

  10. Self-reported Stress/Anxiety

    Time frame · Visits 1 and 7, Up to 7 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline, Visits 1-7, up to 7 weeks

Number of Participants With Stimulant Positive Drug Screen

GroupValue (Participants)
Oxytocin9
Placebo12
Secondary and other outcome results(7)
Secondary outcomeMean· Visits 1 and 7, Up to 7 weeks

Working Alliance Inventory (WAI)

GroupValue (score on a scale)Spread
Oxytocin3.59720.8816
Placebo3.81820.8107
Secondary outcomeMean· Visits 1 and 7, up to 7 weeks

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

GroupValue (Beats/minute)Spread
Oxytocin77.2528.34820
Placebo68.191213.9445
Secondary outcomeMean· Visits 1 and 7, up to 7 weeks

Respiratory Rate in Response to Trier Social Stress Test (TSST).

GroupValue (Breaths/minute)Spread
Oxytocin10.91171.5119
Placebo11.20002.9642
Secondary outcomeMean· Visits 1 and 7, up to 7 weeks

Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).

GroupValue (milliseconds squared)Spread
Oxytocin4.24351.2701
Placebo4.95431.8461
Secondary outcomeMean· Visits 1 and 7, up to 7 weeks

Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).

GroupValue (milliseconds)Spread
Oxytocin26.819641.5701
Placebo48.86548.2147
Secondary outcomeMean· Visits 1 and 7, Up to 7 weeks

Self-reported Stimulant Craving

GroupValue (score on a scale)Spread
Oxytocin2.16671.1827
Placebo1.827271.1707
Secondary outcomeMean· Visits 1-7, Up to 7 weeks

Individual and Group Therapy Attendance Rates

GroupValue (proportion of OTP visits attended)Spread
Oxytocin0.93520.1416
Placebo0.84060.3047

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinOxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.0 / 180 / 181 / 18
PlaceboPlacebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course.0 / 220 / 221 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2014

Can we bottle psychosocial treatments for addiction? The role of oxytocin.

Stauffer et al. 2014The Journal of clinical psychiatrycited by 5

PMID 25295428PMC7448555DOI 10.4088/jcp.14ac09437PUB-25295428

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. At least 18 years old 2. Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland Behavioral Health Clinic Opioid Treatment Program 3. Stable dose of opioid replacement therapy for at least 2 consecutive weeks 4. Veteran 5. One documented urine toxicology screen positive for stimulants in the past 12 months. Exclusion Criteria: 1. Severe neuropsychological disorder 2. Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months 3. Hemodialysis, unless participant can produce urine samples weekly 4. Sensitivity to methylparaben or propylparaben 5. Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control 6. Chronic nasal obstruction, discharge, or bleeding

PepBank is a research reference. Talk to a doctor before you use any peptide.