Clinical trial NCT04736550: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Pain
Keywords: exercise
psychotherapy
residential drug treatment
OUD
chronic pain
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-02-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adherence (% of sessions attended)
timeFrame: through study completion, an average of 8 weeks
Secondary outcomes:
measure: Change in pain
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: Change in weight
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: Change in depression
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: Change in sleep
timeFrame: baseline/pre-intervention and immediately after the intervention
measure: Change in Anxiety
timeFrame: baseline/pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver
state: Colorado
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Nora L Nock, PhD
role: PRINCIPAL_INVESTIGATOR
References: