Cleveland, Ohio 44106

  • Pain

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

STUDY20201427


NCT ID:

NCT04736550


Secondary ID:

R61AT010806


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Western Reserve University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nora L Nock, PhD
Principal Investigator
Case Western Reserve University
Primary Contact:Nora L Nock, PhD
216-368-5653
nln@case.edu

Study Dates

Start Date:February 8, 2021
Completion Date:December 31, 2021
Completion Type:Anticipated
Primary Completion Date:December 31, 2021
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 8, 2021
First Received Date:January 27, 2021

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in sleep
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Anxiety
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description:Higher scores indicate higher levels of cravings.
Outcome Type:Secondary Outcome
Measure:The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description:Higher scores indicate higher levels of cravings.
Outcome Type:Secondary Outcome
Measure:Change in depression
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description: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 depressio
Outcome Type:Secondary Outcome
Measure:Change in weight
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description:The investigators will evaluate potential changes in weight (lbs).
Outcome Type:Secondary Outcome
Measure:Change in pain
Time Frame:baseline/pre-intervention and immediately after the intervention
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Adherence (% of sessions attended)
Time Frame:through study completion, an average of 8 weeks
Safety Issues:False
Description:Percentage of exercise and psychotherapy sessions attended

Study Interventions

Intervention Type:Behavioral
Name:Psychotherapy for Pain (I-STOP)
Description: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".
Arm Name:Assisted Exercise and I-STOP
Intervention Type:Behavioral
Name:Exercise
Description: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").
Arm Name:Assisted Exercise and I-STOP

Study Arms

Study Arm Type:No Intervention
Arm Name:No Exercise (TAU) and No I-STOP (TAU)
Description:Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.
Study Arm Type:Experimental
Arm Name:Voluntary Exercise and No I-STOP (TAU)
Description:Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.
Study Arm Type:Experimental
Arm Name:Assisted Exercise and No I-STOP (TAU)
Description:Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.
Study Arm Type:Experimental
Arm Name:No Exercise (TAU) and I-STOP
Description:Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.
Study Arm Type:Experimental
Arm Name:Voluntary Exercise and I-STOP
Description:Participant will receive Voluntary Rate Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.
Study Arm Type:Experimental
Arm Name:Assisted Exercise and I-STOP
Description:Participant will receive Assisted Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Western Reserve University
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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