Opioid Use Disorder, Pain
Conditions
Brief summary
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.
Interventions
OTHERExercise
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 Pain and Addiction (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
2\^1 x 3\^1 factorial randomized clinical trial
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/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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug cravings | Change from baseline to intervention program completion, an average of 8 weeks | Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Change from baseline to intervention program completion, an average of 8 weeks | 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 |
| Anxiety | Change from baseline to intervention program completion, an average of 8 weeks | 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 |
| Sleep | Change from baseline to intervention program completion, an average of 8 weeks | Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality |
| Drug Cravings using Questionnaire | Change from baseline to intervention program completion, an average of 8 weeks | standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNora L. Nock, PhD
Case Western Reserve University
Outcome results
None listed