NCT03595007|Completed
The Heroes Circle Opioid Project
HCOP
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HCOP
Sponsor study identifier
observational
28
1 country
1
Study Start
August 1, 2018
Actual (reported)Primary Completion
September 30, 2019
Actual (reported)Study Completion
November 30, 2019
Actual (reported)The purpose of this proposed pilot study is to extend the KKC Heroes Circle program to people with opioid use disorder (OUD) who are currently enrolled in methadone maintenance treatment (MMT) and who wish to learn these techniques to reduce their behavioral and physiological dependence on medication. The goal is to engage these MMT patients in a complementary (non-pharmacological) therapeutic activity that may improve their self-efficacy and personal control, reduce the impact of stressors and chronic pain, drug craving, affective and physical function, and lower reliance on pharmacological interventions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2018
Actual (reported)July 23, 2018
Actual (reported)August 1, 2018
Actual (reported)September 30, 2019
Actual (reported)November 30, 2019
Actual (reported)Change in methadone dose
Extracted from the patient's medical record
Once at baseline and twice-weekly over a 12-week period.
Drug-free urine test results (<300 ng/ml) for opioids, cocaine, benzodiazepines, and barbiturates (<300 ng/ml), and cannabinoids (<50 ng/ml).
Extracted from the patient's medical record
Once at baseline and twice-weekly over a 12-week period.
Change in self-report of pain, drug craving, anxiety, anger and depression
Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period.
Change in self-report of the following feelings and emotions: Afraid, Ashamed, Hostile, Nervous and Upset
Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period.
Change in heart rate biomarker (beats per minute (bpm)
Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.
Change in blood pressure (Systolic and Diastolic mmHg) biomarker
Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.
Change in saliva cortisol biomarkers
Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.
Individual instruction on how to lower stress and life challenges. Patient and martial artist will work together to identify obstacles that interfere with methadone goal reduction. Training will include learning certain martial arts rituals and breathing techniques. Patients will receive audio meditations for smart phone devices and regular reminders to practice. Each weekly meeting will be supplemented by 3 phone calls per week from the martial artist to support the training. Additionally a virtual reality device will be used to help lower stress.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
People with opioid use disorder (OUD), currently enrolled in methadone maintenance treatment (MMT) who wish to learn techniques to reduce their behavioral and physiological dependence on medication.
Wayne State University
Detroit, Michigan, 48201, United States
Mark Greenwald, PhD
Wayne State University
28 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2018
First Posted
July 23, 2018
Study Start
August 1, 2018
Actual (reported)Transforming Recovery Through Exercise and Community
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2019
Actual (reported)Study Completion
November 30, 2019
Actual (reported)Last Updated
August 30, 2024
Record last verified: 2024-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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