The Heroes Circle Opioid Project

NCT03595007 | Completed

• 1 other identifier: HCOP
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (7)

• 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.

Study Arms (3)

Phase 1

Behavioral: Kids Kicking Cancer program

Phase 2

Behavioral: Kids Kicking Cancer program

Phase 3

Behavioral: Kids Kicking Cancer program

Interventions

Kids Kicking Cancer program BEHAVIORAL

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.

Phase 1; Phase 2; Phase 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Current diagnosis of Opioid Use Disorder
• Stable daily methadone dose for at least one month prior to enrollment
• Desire to reduce the daily methadone dose at least 20%.

You may not qualify if:

• Pregnant (urine test) or lactating (self-report)
• Current severe Axis I psychiatric disorder, e.g. psychosis, bipolar disorder
• Suicidal ideation/attempt during the past year
• Medical contraindications to the proposed therapeutic program, in the opinion of the clinic physician.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mark Greenwald, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 23, 2018
• Study Start: August 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)