Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
A legfontosabb adatok
- Ki végzi
- Case Western Reserve University
- Hol
- Cleveland és Denver (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Fut, nem toboroz
- Résztvevők
- 198 fő, tervezett
- Kezdés
- 2023. febr. 10.
- Várható befejezés
- 2028. júl. 5.
- A vizsgálat típusa
- Beavatkozással járó, 6 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Exercise
- Psychotherapy Pain and Addiction (I-STOP)
- A regiszteradat frissítve
- 2026. március 24.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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))
Ki nem vehet részt
- Any substantive contraindications to exercise
- Psychiatrically unstable
- Pregnant women
- Non-English speaking adults
- Adults unable to provide informed written consent
Helyszínek itt: Egyesült Államok
- Case Western Reserve UniversityCleveland, Egyesült Államok
- University of Colorado at DenverDenver, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 6 csoportja
- Assisted Exercise and I-STOPA vizsgált kezelés
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).
Kezelés: Exercise és Psychotherapy Pain and Addiction (I-STOP)
- Voluntary Exercise and I-STOPA vizsgált kezelés
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).
Kezelés: Exercise és Psychotherapy Pain and Addiction (I-STOP)
- Assisted Exercise and No I-STOPA vizsgált kezelés
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).
Kezelés: Exercise
- Voluntary Exercise and No I-STOPA vizsgált kezelés
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).
Kezelés: Exercise
- No Exercise and I-STOPA vizsgált kezelés
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).
Kezelés: Psychotherapy Pain and Addiction (I-STOP)
- No Exercise and No I-STOPNincs vizsgálati kezelés, összehasonlításként
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).
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
- A regiszteradat frissítve
- 2026. március 24.