Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R33AT010806-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted Exercise and I-STOP | Experimental | 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). |
|
| Voluntary Exercise and I-STOP | Experimental | 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). |
|
| Assisted Exercise and No I-STOP | Experimental | 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). |
|
| Voluntary Exercise and No I-STOP | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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"). |
| Measure | Description | Time Frame |
|---|---|---|
| Drug cravings | Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings; | Change from baseline to intervention program completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 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 | Change from baseline to intervention program completion, an average of 8 weeks |
| Anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nora L. Nock, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado at Denver | Denver | Colorado | 80217 | United States | ||
| Case Western Reserve University |
Data will be shared as required by NIH HEAL and as deemed acceptable by governing IRB, HIPPA and other regulations.
Not provided
Not provided
Not provided
Not provided
Not provided
2^1 x 3^1 factorial randomized clinical trial
Not provided
Not provided
Not provided
|
| No Exercise and I-STOP | Experimental | 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). |
|
| No Exercise and No I-STOP | No Intervention | 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). |
|
| Psychotherapy Pain and Addiction (I-STOP) | Behavioral | 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". |
|
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 |
| Change from baseline to intervention program completion, an average of 8 weeks |
| Sleep | Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality | Change from baseline to intervention program completion, an average of 8 weeks |
| Drug Cravings using Questionnaire | standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings | Change from baseline to intervention program completion, an average of 8 weeks |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided