Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04736550
• Other study ID #: STUDY20201427
• Secondary ID: R61AT010806
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2022
• 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 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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").
• Psychotherapy 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".

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	Adherence (% of sessions attended)	Percentage of exercise and psychotherapy sessions attended	through study completion, an average of 8 weeks
Secondary	Change in pain	The investigators will evaluate potential changes in pain using a cold pressor pain task. Pain sensitivity is the time spent in a cold water bath until the first report of pain and pain tolerance is the total time in the cold water bath.	baseline/pre-intervention and immediately after the intervention
Secondary	Change in weight	The investigators will evaluate potential changes in weight (lbs).	baseline/pre-intervention and immediately after the intervention
Secondary	Change in depression	The investigators will evaluate potential changes in depression using 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.	baseline/pre-intervention and immediately after the intervention
Secondary	The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)	Higher scores indicate higher levels of cravings.	baseline/pre-intervention and immediately after the intervention
Secondary	Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)	Higher scores indicate higher levels of cravings.	baseline/pre-intervention and immediately after the intervention
Secondary	Change in sleep	The investigators will evaluate potential changes in sleep using self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI). Total Score range: 0-21; Higher scores indicate poorer sleep quality.	baseline/pre-intervention and immediately after the intervention
Secondary	Change in Anxiety	The investigators will evaluate potential changes in depression using self-report, standardized questionnaire (Anxiety sub-scale in Hospital Anxiety and Depression Scale, HADS). Total Score range: 0-21; Higher scores indicate higher levels of anxiety.	baseline/pre-intervention and immediately after the intervention