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

Case Western Reserve University

Status: Active, not recruiting

Conditions: Opioid Use Disorder; Pain

Treatments: Behavioral: Psychotherapy Pain and Addiction (I-STOP); Other: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05688410

5R33AT010806-03 (U.S. NIH Grant/Contract)

STUDY20201427 - R33 Phase

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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
• Psychiatrically unstable
• Pregnant women
• Non-English speaking adults
• Adults unable to provide informed written consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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198 participants in 6 patient groups

Assisted Exercise and I-STOP

Experimental group

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).

Treatment:

Other: Exercise

Behavioral: Psychotherapy Pain and Addiction (I-STOP)

Voluntary Exercise and I-STOP

Experimental group

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).

Treatment:

Other: Exercise

Behavioral: Psychotherapy Pain and Addiction (I-STOP)

Assisted Exercise and No I-STOP

Experimental group

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).

Treatment:

Other: Exercise

Voluntary Exercise and No I-STOP

Experimental group

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).

Treatment:

Other: Exercise

No Exercise and I-STOP

Experimental group

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).

Treatment:

Behavioral: Psychotherapy Pain and Addiction (I-STOP)

No Exercise and No I-STOP

No Intervention group

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).