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

Primary Purpose

Opioid-use Disorder, Pain

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Psychotherapy for Pain (I-STOP)

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring exercise, psychotherapy, residential drug treatment, OUD, chronic pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado at Denver
Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Arm Label

Assisted Exercise and I-STOP

Voluntary Exercise and I-STOP

No Exercise (TAU) and I-STOP

Assisted Exercise and No I-STOP (TAU)

Voluntary Exercise and No I-STOP (TAU)

No Exercise (TAU) and No I-STOP (TAU)

Arm 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.

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.

Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.

Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.

Outcomes

Primary Outcome Measures

Adherence (% of sessions attended)

Percentage of exercise and psychotherapy sessions attended

Secondary Outcome Measures

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.

Change in weight

The investigators will evaluate potential changes in weight (lbs).

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.

The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)

Higher scores indicate higher levels of cravings.

Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)

Higher scores indicate higher levels of cravings.

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.

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.

Full Information

NCT ID

NCT04736550

First Posted

January 27, 2021

Last Updated

May 11, 2023

Sponsor

Case Western Reserve University

Collaborators

University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT04736550

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

Collaborators

University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Pain

Keywords

exercise, psychotherapy, residential drug treatment, OUD, chronic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

In the pilot trial (R61 Phase), the investigators will use a multi-phase optimization trial (MOST) approach to help identify which components of the exercise and psychotherapy for pain treatment program are viable and worth retaining in the planned fully powered trial (R33 Phase). In the R61 Phase/Pilot Trial, the investigators will have two intervention components: 1) exercise with 3 levels ('assisted', voluntary, none/treatment as usual (TAU); and, 2) psychotherapy for pain (I-STOP) with 2 levels (Yes/I-STOP, No/TAU). All participants will receive also receive the treatment as usual at their residential drug treatment program and any medication assisted treatment (MAT). This corresponds to a 2^1 x 3 1 full factorial with six experimental conditions.

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Assisted Exercise and I-STOP

Arm Type

Experimental

Arm 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.

Arm Title

Voluntary Exercise and I-STOP

Arm Type

Experimental

Arm 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.

Arm Title

No Exercise (TAU) and I-STOP

Arm Type

Experimental

Arm Description

Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.

Arm Title

Assisted Exercise and No I-STOP (TAU)

Arm Type

Experimental

Arm Description

Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Arm Title

Voluntary Exercise and No I-STOP (TAU)

Arm Type

Experimental

Arm Description

Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Arm Title

No Exercise (TAU) and No I-STOP (TAU)

Arm Type

No Intervention

Arm Description

Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention 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").

Intervention Type

Behavioral

Intervention Name(s)

Psychotherapy for Pain (I-STOP)

Intervention 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".

Primary Outcome Measure Information:

Title

Adherence (% of sessions attended)

Description

Percentage of exercise and psychotherapy sessions attended

Time Frame

through study completion, an average of 8 weeks

Secondary Outcome Measure Information:

Title

Change in pain

Description

Time Frame