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The Heroes Circle Opioid Project (HCOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595007
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

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.


Condition or disease Intervention/treatment
Opioid-use Disorder Behavioral: Kids Kicking Cancer program

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Heroes Circle Opioid Project
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
Phase 1 Behavioral: Kids Kicking Cancer program
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 2 Behavioral: Kids Kicking Cancer program
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 3 Behavioral: Kids Kicking Cancer program
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.




Primary Outcome Measures :
  1. Change in methadone dose [ Time Frame: Once at baseline and twice-weekly over a 12-week period. ]
    Extracted from the patient's medical record

  2. Drug-free urine test results (<300 ng/ml) for opioids, cocaine, benzodiazepines, and barbiturates (<300 ng/ml), and cannabinoids (<50 ng/ml). [ Time Frame: Once at baseline and twice-weekly over a 12-week period. ]
    Extracted from the patient's medical record


Secondary Outcome Measures :
  1. Change in self-report of pain, drug craving, anxiety, anger and depression [ Time Frame: Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period. ]
    Measured by Visual Analog Scales (0: Not all all (Better outcome) - 10: Extremely (Worse outcome)

  2. Change in self-report of the following feelings and emotions: Afraid, Ashamed, Hostile, Nervous and Upset [ Time Frame: Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period. ]
    Measured by Negative Affect Schedule (1: Very slightly or not at all (Better outcome), 2: A little, 3: Moderately, 4: Quite a bit, 5: Extremely (Worse outcome)

  3. Change in heart rate biomarker (beats per minute (bpm) [ Time Frame: Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections. ]
    The investigators will obtain pre and post session heart rate measurements collected using non-invasive vital monitor

  4. Change in blood pressure (Systolic and Diastolic mmHg) biomarker [ Time Frame: Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections. ]
    The investigators will obtain pre and post session blood pressure measurements collected using non-invasive vital monitor

  5. Change in saliva cortisol biomarkers [ Time Frame: Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections. ]
    The investigators will obtain pre and post session saliva samples to measure saliva cortisol collected using Salivette held under tongue

  6. Change in C-reactive protein biomarkers [ Time Frame: Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections. ]
    The investigators will obtain pre and post session saliva samples to measure C-reactive protein collected using Salivette held under tongue

  7. Percentage of patients who reduce methadone dose at least 20 percent [ Time Frame: Once at baseline and twice-weekly over a 12-week period. ]
    Extracted from the patient's medical record



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03595007


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Mark Greenwald, PhD Wayne State University
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Responsible Party: Mark Greenwald, PhD, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03595007    
Other Study ID Numbers: HCOP
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No