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

Case Western Reserve University

Status: Active, not recruiting

Conditions: Opioid-use Disorder; Pain

Treatments: Behavioral: Psychotherapy for Pain (I-STOP); Behavioral: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04736550

STUDY20201427

R61AT010806 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 63 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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63 participants in 6 patient groups

Assisted Exercise and I-STOP

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Psychotherapy for Pain (I-STOP)

Voluntary Exercise and I-STOP

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Psychotherapy for Pain (I-STOP)

No Exercise (TAU) and I-STOP

Experimental group

Description:

Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.

Treatment:

Behavioral: Psychotherapy for Pain (I-STOP)

Assisted Exercise and No I-STOP (TAU)

Experimental group

Description:

Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Treatment:

Behavioral: Exercise

Voluntary Exercise and No I-STOP (TAU)

Experimental group

Description:

Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Treatment:

Behavioral: Exercise

No Exercise (TAU) and No I-STOP (TAU)

No Intervention group

Description:

Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.