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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well exercise and psychotherapy can be combined to help individuals with opioid use disorder (OUD) manage pain during residential treatment. Participants will be divided into groups to test different combinations of stationary cycling (either assisted or voluntary) and a specialized talk therapy for pain called I-STOP. The trial will assess whether these activities can reduce pain, cravings, depression, and anxiety, as well as improve weight and sleep. Suitable candidates include those in a residential drug treatment program with OUD and chronic pain who can safely engage in exercise activities. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies while contributing to valuable research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise, whether done independently or with assistance, is generally safe for people with opioid use disorder (OUD). Studies have found that physical activity can support recovery and might reduce the need for opioids. Participants in these studies reported that exercise aids their treatment, with only a few minor side effects noted.

For the psychotherapy for pain (I-STOP) component, specific safety information is limited. However, psychotherapy is a common and safe treatment for many conditions, including pain, and usually poses less risk than medication.

Overall, the treatments in this trial—exercise and psychotherapy—are generally safe and have proven helpful for people with similar issues in other settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines exercise and psychotherapy for pain management in opioid use disorder, offering a holistic approach that differs from standard treatments like medication-assisted therapy and behavioral interventions. Exercise, both voluntary and assisted, could improve physical health and reduce pain perception, while the innovative I-STOP psychotherapy focuses specifically on pain management, addressing a critical component often overlooked in opioid use disorder treatment. This dual approach has the potential to enhance recovery outcomes by not only targeting the addiction itself but also alleviating the underlying pain that can drive opioid misuse.

What evidence suggests that this trial's treatments could be effective for opioid use disorder and pain?

This trial will evaluate the effects of different interventions for opioid use disorder and pain. Participants in one arm will receive voluntary exercise, which studies have shown can be beneficial for individuals with substance use disorders, including opioid use disorder (OUD). Regular exercise enhances the brain's reward system, often impacted by substance use. Both assisted and voluntary exercise may also alleviate pain, a common issue for those with OUD.

Another arm will involve psychotherapy for pain, specifically I-STOP. Research indicates that pain therapy, such as I-STOP, can help manage long-term pain and reduce opioid dependence. Mind-body therapies, similar to I-STOP, have shown promise in improving pain management for those using opioids. These methods could potentially improve pain, reduce cravings, and enhance overall mental well-being for individuals dealing with OUD and pain. ^{3 4 5 6 7}

Who Is on the Research Team?

Nora L Nock, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553166/

Opioid Use Disorder: Evaluation and Management - NCBI - NIH Cognitive behavioral therapy is most effective if combined with medications; however, there are mixed results on its effectiveness.[12][24].

2. sciencedirect.com sciencedirect.com/science/article/pii/S0740547217304828

Effects of medication assisted treatment (MAT) for opioid ... This systematic review synthesizes evidence on the effects of Medication-Assisted Treatment (MAT) for opioid use disorder (OUD) on functional outcomes.

3. dph.illinois.gov dph.illinois.gov/topics-services/opioids/treatment/mat-faq.html

Medication-Assisted Treatment FAQ Despite decades of clinical research showing the efficacy of MAT in treatment OUD, MAT is still not widely used. Fewer than half of privately-funded substance ...

4. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... The systematic review addressed the effectiveness of long-term opioid therapy for outcomes related to pain, function, and quality of life ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMra1507771

Opioid Abuse in Chronic Pain — Misconceptions and ... We draw on recent research to address common misconceptions regarding the abuse-related risks of opioid analgesics and highlight strategies to minimize those ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10003472/

The Role of Physical Exercise in Opioid Substitution Therapy This review focuses on the possible mechanisms that contribute to the beneficial effects of exercise on the treatment of OUDs.

7. sciencedirect.com sciencedirect.com/science/article/pii/S221133552300284X

Barriers, perceived benefits and preferences to exercise in ... Our findings indicate that adults with OUD believe exercise is a valuable tool to use in their recovery but they encounter several barriers.