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Trial record 24 of 121 for:    stress testing OR exercise echocardiogram OR myocardial perfusion imaging | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Stimulant Oxytocin Study (SOS)

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ClinicalTrials.gov Identifier: NCT03016598
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Cocaine Use & Co-occuring Opioid Use Disorders Drug: Intranasal oxytocin Drug: Intranasal placebo Phase 2

Detailed Description:
High rates of substance use disorders (SUDs) in Veterans compared to the general population are heavily influenced by psychosocial factors - such as difficulty reintegrating into civilian life due to avoidance of vital support systems - leading to disproportionately elevated unmet addiction treatment needs. Although the gold standard for treatment for most SUDs involves pharmacological interventions, there are currently no effective pharmacological interventions approved by the Federal Drug Administration for stimulant users, who have the most difficulty adhering to treatment programs and the most susceptibility to stress-induced relapse of any SUD. Administering oxytocin, a mammalian neuropeptide, intranasally to healthy controls facilitates the stress-buffering properties of social support. Oxytocin may also have an independent role in mitigating the symptoms of SUDs. For example, in animal models of addiction, oxytocin administration directly reduces tolerance, withdrawal effects, self-administration, and stress-induced reinstatement of drug seeking for a range of addictive substances. A more integrated understanding of oxytocin's distinct effects on the behavior and psychology of 1) addiction, 2) sociality, and 3) stress reactivity could be the key to defining oxytocin's role in SUD treatment. This study proposes to translate promising preclinical and early proof-of-concept clinical results related to the anti-addiction, pro-social, and stress-tempering properties of oxytocin administration in Veterans with moderate-severe cocaine use disorder (CUD) enrolled in a opioid replacement therapy (ORT) program for cooccurring opioid use disorder (OUD) at the San Francisco VA Medical Center (SFVAMC). The investigators' primary outcome is Aim 1) reduction in cocaine use, as measured by quantitative urine levels of cocaine metabolite. Secondarily, the investigators will focus on Aim 2) improving psychosocial treatment engagement (social support) and Aim 3) mitigating social stress-related relapse, targeting two important barriers to CUD recovery likely to respond to oxytocin administration

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Phase 0 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 cocaine use disorder 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.
Drug: Intranasal oxytocin
Each Veteran with CUD and 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.
Other Name: Syntocinon

Placebo Comparator: Placebo
Phase 0 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 cocaine use disorder 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.
Drug: Intranasal placebo
Each Veteran with CUD and 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.
Other Name: Saline placebo




Primary Outcome Measures :
  1. quantitative levels of cocaine and metabolites in urine [ Time Frame: Up to 6 weeks ]
    Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing cocaine use.


Secondary Outcome Measures :
  1. Working Alliance Inventory (WAI) [ Time Frame: Up to 6 weeks ]
    Aim 2: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by the WAI, an inventory of therapeutic alliance.

  2. Psychophysiological measures [ Time Frame: up to 6 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).

  3. Self-reported stimulant craving [ Time Frame: Up to 6 weeks ]
    Aim 4: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant craving in response the TSST.

  4. Individual and Group therapy attendance Rates [ Time Frame: Up to 6 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.

  5. Stress Biomarkers [ Time Frame: up to 6 weeks ]
    Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.

  6. Self-reported stress/anxiety [ Time Frame: Up to 6 weeks ]
    Aim 7: To evaluate the effectiveness of intranasal oxytocin on reducing self-reported stress/anxiety levels in response to the TSST.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old
  2. Enrolled as a patient at the SFVAMC 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 cocaine in the past month

Exclusion Criteria:

  1. DSM-V criteria for previous or current schizophrenia, schizoaffective disorder, or bipolar disorder; severe neuropsychological disorder, premenstrual dysphoric disorder, or current moderate-severe alcohol use 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 potassium sorbate
  5. Using hormone supplementation
  6. Using 5HT1a agonist/antagonist
  7. Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control
  8. Chronic nasal obstruction, discharge, or bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016598


Contacts
Contact: Christopher Stauffer, MD (415) 221-4810 Christopher.Stauffer@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Christopher Stauffer, MD    415-221-4810    Christopher.Stauffer@va.gov   
Principal Investigator: Christopher Stauffer, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Christopher Stauffer, MD San Francisco VA Medical Center, San Francisco, CA

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03016598     History of Changes
Other Study ID Numbers: NURA-014-16S
1IK2CX001495-01 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
oxytocin
substance-related disorders
Opioid Replacement Therapy
Psychophysiology
Stress Biomarkers

Additional relevant MeSH terms:
Oxytocin
Cocaine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents