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

Study Overview
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Brief Summary
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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.

Official Title
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Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)

Conditions
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Opioid Use Disorder, Pain

Intervention / Treatment
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* Other: Exercise
* Behavioral: Psychotherapy Pain and Addiction (I-STOP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2^1 x 3^1 factorial randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted Exercise and I-STOP<br>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). | Other: Exercise<br>* 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).<br>Behavioral: Psychotherapy Pain and Addiction (I-STOP)<br>* 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.<br>|
| Experimental: Voluntary Exercise and I-STOP<br>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). | Other: Exercise<br>* 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).<br>Behavioral: Psychotherapy Pain and Addiction (I-STOP)<br>* 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.<br>|
| Experimental: Assisted Exercise and No I-STOP<br>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). | Other: Exercise<br>* 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).<br>|
| Experimental: Voluntary Exercise and No I-STOP<br>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). | Other: Exercise<br>* 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).<br>|
| Experimental: No Exercise and I-STOP<br>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). | Behavioral: Psychotherapy Pain and Addiction (I-STOP)<br>* 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.<br>|
| No Intervention: No Exercise and No I-STOP<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug cravings | Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings; | Change from baseline to intervention program completion, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline to intervention program completion, an average of 8 weeks | 
| 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 | Change from baseline to intervention program completion, an average of 8 weeks | 
| Sleep | Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality | Change from baseline to intervention program completion, an average of 8 weeks | 
| Drug Cravings using Questionnaire | standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings | Change from baseline to intervention program completion, an average of 8 weeks |