Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders (EXPO Pilot Trial)

Study Overview
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Brief Summary
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The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight 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 Pilot Trial

Conditions
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Opioid-use Disorder, Pain

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Psychotherapy for Pain (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 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) and 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: In the pilot trial (R61 Phase), the investigators will use a multi-phase optimization trial (MOST) approach to help identify which components of the exercise and psychotherapy for pain treatment program are viable and worth retaining in the planned fully powered trial (R33 Phase). In the R61 Phase/Pilot Trial, the investigators will have two intervention components: 1) exercise with 3 levels ('assisted', voluntary, none/treatment as usual (TAU); and, 2) psychotherapy for pain (I-STOP) with 2 levels (Yes/I-STOP, No/TAU). All participants will receive also receive the treatment as usual at their residential drug treatment program and any medication assisted treatment (MAT). This corresponds to a 2^1 x 3 1 full factorial with six experimental conditions.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted Exercise and I-STOP<br>Participant will receive Assisted Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week. | Behavioral: 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 for Pain (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>Participant will receive Voluntary Rate Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week. | Behavioral: 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 for Pain (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: No Exercise (TAU) and I-STOP<br>Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week. | Behavioral: Psychotherapy for Pain (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 (TAU)<br>Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week. | Behavioral: 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 (TAU)<br>Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week. | Behavioral: 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>|
| No Intervention: No Exercise (TAU) and No I-STOP (TAU)<br>Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (% of sessions attended) | Percentage of exercise and psychotherapy sessions attended | through study completion, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | The investigators will evaluate potential changes in pain using a cold pressor pain task. Pain sensitivity is the time spent in a cold water bath until the first report of pain and pain tolerance is the total time in the cold water bath. | baseline/pre-intervention and immediately after the intervention | 
| Change in weight | The investigators will evaluate potential changes in weight (lbs). | baseline/pre-intervention and immediately after the intervention | 
| Change in depression | The investigators will evaluate potential changes in depression using 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. | baseline/pre-intervention and immediately after the intervention | 
| The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS) | Higher scores indicate higher levels of cravings. | baseline/pre-intervention and immediately after the intervention | 
| Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire) | Higher scores indicate higher levels of cravings. | baseline/pre-intervention and immediately after the intervention | 
| Change in sleep | The investigators will evaluate potential changes in sleep using self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI). Total Score range: 0-21; Higher scores indicate poorer sleep quality. | baseline/pre-intervention and immediately after the intervention | 
| Change in Anxiety | The investigators will evaluate potential changes in depression using self-report, standardized questionnaire (Anxiety sub-scale in Hospital Anxiety and Depression Scale, HADS). Total Score range: 0-21; Higher scores indicate higher levels of anxiety. | baseline/pre-intervention and immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OUD, exercise, psychotherapy, residential drug treatment, chronic pain