Exercise + Psychotherapy for Opioid Use Disorder and Pain

Recruiting at 1 trial location

Overseen By Nora L Nock, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Exercise contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

63 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment Exercise + Psychotherapy for Opioid Use Disorder and Pain?

Research shows that exercise can help people with opioid use disorder by improving brain health, reducing anxiety and depression, and managing pain. Exercise is also linked to better mood and quality of life, making it a promising addition to treatment for opioid use disorder and pain. ^{1 2 3 4 5}

Is exercise and psychotherapy safe for people with opioid use disorder and pain?

Exercise is generally considered safe for individuals with opioid use disorder and can improve mood, reduce pain, and enhance quality of life. Participants in studies have found exercise to be an acceptable and feasible treatment option, though more research with larger groups is needed to confirm these findings. ^{1 3 6 7 8}

How is the Exercise + Psychotherapy treatment for opioid use disorder and pain different from other treatments?

This treatment is unique because it combines exercise and psychotherapy, which can improve brain health, sleep, and mood while reducing pain, anxiety, and depression. Unlike traditional drug treatments, it uses physical activity to enhance the body's natural pain control systems and improve overall quality of life. ^{1 2 3 9 10}

Research Team

Nora L Nock, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for adults aged 18-65 with opioid use disorder and pain, who are currently in a residential drug treatment program. Participants must have approval to exercise from medical staff and be diagnosed with OUD or poly-substance use that includes opioids.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive exercise and psychotherapy interventions, including 'assisted' rate cycling, voluntary rate cycling, and I-STOP for pain management

8 weeks

3 visits per week for exercise, 1 visit per week for psychotherapy

Follow-up

Participants are monitored for changes in weight, pain, depression, anxiety, sleep, and cravings after treatment

4 weeks

Treatment Details

Interventions

• Exercise
• Psychotherapy for Pain (I-STOP)

Trial Overview The EXPO pilot trial is testing the integration of 'assisted' rate cycling, voluntary rate cycling, and specialized psychotherapy (I-STOP) into drug treatment programs to see if they help manage pain, cravings, depression, anxiety, weight issues, and sleep problems in people with opioid addiction.

Participant Groups

Group I: Voluntary Exercise and No I-STOP (TAU) Experimental Treatment 1 Intervention

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

Group II: Voluntary Exercise and I-STOP Experimental Treatment 2 Interventions

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.

Group III: No Exercise (TAU) and I-STOP Experimental Treatment 1 Intervention

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

Group IV: Assisted Exercise and No I-STOP (TAU) Experimental Treatment 1 Intervention

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

Group V: Assisted Exercise and I-STOP Experimental Treatment 2 Interventions

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.

Group VI: No Exercise (TAU) and No I-STOP (TAU) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Exercise interventions for individuals with opioid use disorder (OUD) have shown positive effects on immune function, pain reduction, cravings, anxiety, depression, mood, and overall quality of life, based on a review of 13 studies.

While exercise is considered an acceptable and feasible adjunct treatment for OUD, most studies involved small sample sizes, highlighting the need for further research with larger groups to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. Shreffler, J., Genova, G., Huecker, M.[2022]

Physical activity interventions for patients undergoing opioid substitution therapy have been shown to improve physical fitness and reduce substance use, based on a systematic review of 10 studies.

Despite the positive findings, the majority of studies in this area lack high methodological quality and sufficient power, indicating a need for more robust clinical trials to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Physical Activity in Opioid Substitution Therapy: A Systematic Review of Interventional and Observational Studies. Alpers, SE., Furulund, E., Pallesen, S., et al.[2022]

In a study of 298 detoxification patients over six months, higher baseline pain levels were linked to worse psychiatric and medical outcomes, highlighting the negative impact of chronic pain on recovery.

Regular exercise at baseline was associated with improved psychiatric severity and greater abstinence self-efficacy, particularly benefiting those with less intense pain, suggesting that exercise can be a valuable part of treatment for detoxification patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health outcomes among detoxification patients: The role of chronic pain. Woodhead, EL., Brief, D., Below, M., et al.[2021]

Interdisciplinary pain rehabilitation programs (IPRPs) significantly improve both self-reported and performance-based functional outcomes in patients with chronic pain, regardless of whether they are using opioids or not, as shown in a study involving two cohorts over a 3-week treatment period.

The study found that improvements in function were evident immediately after treatment and persisted for at least 6 months, highlighting the effectiveness of IPRPs in helping patients discontinue opioid use while enhancing their physical and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. Gilliam, WP., Craner, JR., Cunningham, JL., et al.[2022]

A multisite randomized controlled trial involving 160 veterans with chronic pain and opioid use disorder will evaluate the efficacy of an integrated treatment combining Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, focusing on pain interference and hazardous opioid use.

The study aims to address a significant gap in treatment options by assessing outcomes over 12 months, including pain interference and opioid misuse, which could lead to improved care for veterans on buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Vowles, KE., Witkiewitz, K., Clarke, E., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise therapy for chronic pain. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Physical Activity in Opioid Substitution Therapy: A Systematic Review of Interventional and Observational Studies. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Health outcomes among detoxification patients: The role of chronic pain. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Regular physical activity reduces the percentage of spinally projecting neurons that express mu-opioid receptors from the rostral ventromedial medulla in mice. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An fMRI study on the acute effects of exercise on pain processing in trained athletes. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Attitudes towards exercise among substance using older adults living with HIV and chronic pain. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy for Chronic Pain Mitigation and Opioid Use Reduction Among People Living with Human Immunodeficiency Virus in Atlanta, GA: A Descriptive Case Series. [2021]