search
Back to results

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase) (EXPO-R33)

Primary Purpose

Opioid Use Disorder, Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Psychotherapy Pain and Addiction (I-STOP)
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 65 years old Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP)) Exclusion Criteria: Any substantive contraindications to exercise

Sites / Locations

  • University of Colorado at Denver
  • Case Western Reserve UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Assisted Exercise and I-STOP

Voluntary Exercise and I-STOP

Assisted Exercise and No I-STOP

Voluntary Exercise and No I-STOP

No Exercise and I-STOP

No Exercise and No I-STOP

Arm Description

Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP).

Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP).

Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

Outcomes

Primary Outcome Measures

Drug cravings
Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;

Secondary Outcome Measures

Depression
Change in depression: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; higher scores indicate higher levels of depression
Anxiety
Change in anxiety: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; Higher scores indicate higher levels of anxiety
Sleep
Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality
Drug Cravings using Questionnaire
standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings

Full Information

First Posted
December 23, 2022
Last Updated
May 11, 2023
Sponsor
Case Western Reserve University
Collaborators
University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT05688410
Brief Title
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
Acronym
EXPO-R33
Official Title
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2^1 x 3^1 factorial randomized clinical trial
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assisted Exercise and I-STOP
Arm Type
Experimental
Arm Description
Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP).
Arm Title
Voluntary Exercise and I-STOP
Arm Type
Experimental
Arm Description
Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP).
Arm Title
Assisted Exercise and No I-STOP
Arm Type
Experimental
Arm Description
Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
Arm Title
Voluntary Exercise and No I-STOP
Arm Type
Experimental
Arm Description
Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
Arm Title
No Exercise and I-STOP
Arm Type
Experimental
Arm Description
Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
Arm Title
No Exercise and No I-STOP
Arm Type
No Intervention
Arm Description
Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants who are randomized to exercise will be perform exercise on stationary bikes. Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted (exercise) bike").
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy Pain and Addiction (I-STOP)
Intervention Description
Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). I-STOP uses empirically validated pain psychotherapy approaches targeted to patients with an OUD using psycho-physiological self-regulation components and biofeedback with "Bio-dots".
Primary Outcome Measure Information:
Title
Drug cravings
Description
Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;
Time Frame
Change from baseline to intervention program completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
Change in depression: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; higher scores indicate higher levels of depression
Time Frame
Change from baseline to intervention program completion, an average of 8 weeks
Title
Anxiety
Description
Change in anxiety: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; Higher scores indicate higher levels of anxiety
Time Frame
Change from baseline to intervention program completion, an average of 8 weeks
Title
Sleep
Description
Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality
Time Frame
Change from baseline to intervention program completion, an average of 8 weeks
Title
Drug Cravings using Questionnaire
Description
standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings
Time Frame
Change from baseline to intervention program completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 65 years old Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP)) Exclusion Criteria: Any substantive contraindications to exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nora L. Nock, PhD
Phone
216-368-5653
Email
nln@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora L. Nock, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora L Nock, PhD
Phone
216-368-5653
Email
nln@case.edu
First Name & Middle Initial & Last Name & Degree
Amy Wachholtz, PhD
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora L Nock, PhD
Phone
216-368-5653
Email
nln@case.edu
First Name & Middle Initial & Last Name & Degree
Nora L Nock, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared as required by NIH HEAL and as deemed acceptable by governing IRB, HIPPA and other regulations.

Learn more about this trial

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)

We'll reach out to this number within 24 hrs