Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)

Pain Clinical Trial

— EXPO-R33  

Official title:

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688410
• Other study ID #: STUDY20201427 - R33 Phase
• Secondary ID: R33AT010806
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2023
• Source: Case Western Reserve University
• Contact: Nora L. Nock, PhD
• Phone: 216-368-5653
• Email: nln[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Pain
• Substance-Related Disorders

Intervention

Other:
• Exercise
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").

Behavioral:
• Psychotherapy 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".

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio
United States	University of Colorado at Denver	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
Case Western Reserve University	National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Anxiety	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
Secondary	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
Secondary	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