Opioid-use Disorder, Pain
Conditions
Keywords
exercise, psychotherapy, residential drug treatment, OUD, chronic pain
Brief summary
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.
Interventions
BEHAVIORALExercise
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").
BEHAVIORALPsychotherapy for Pain (I-STOP)
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".
Sponsors
Case Western Reserve University
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (% of sessions attended) | through study completion, an average of 8 weeks | Percentage of exercise and psychotherapy sessions attended |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNora L Nock, PhD
Case Western Reserve University
Outcome results
None listed