Exercise + Psychotherapy for Opioid Use Disorder

(EXPO-R33 Trial)

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, Psychiatric instability, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how exercise and psychotherapy can reduce cravings in adults with opioid use disorder. It examines different combinations: some participants will engage in cycling exercises, either independently or with a bike that assists in faster pedaling, while others will receive a specialized psychotherapy program (talk therapy). The trial also evaluates whether these treatments can improve depression, anxiety, and sleep. It is ideal for individuals in a residential drug treatment program who have an opioid use disorder and experience chronic pain. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that could enhance the recovery journey.

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's best to discuss this with the trial coordinators or your doctor.

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

Research shows that exercise, whether assisted or independent, is generally safe and can aid in treating opioid use disorder (OUD). Studies suggest that physical activity reduces cravings and improves overall health. Participants in these studies, many with OUD, reported feeling better and experiencing fewer cravings after regular exercise.

Regarding I-STOP psychotherapy, combining therapy with other treatments effectively addresses substance use disorders. This approach helps individuals manage addiction and improve recovery. Sources report no specific safety concerns linked to I-STOP therapy, indicating it is well-tolerated.

In summary, both exercise and I-STOP therapy have promising safety records based on past research. They are generally well-tolerated and beneficial for individuals with OUD. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining exercise and psychotherapy for opioid use disorder because it brings a fresh approach to treatment. Unlike standard treatments, which often rely on medication-assisted therapies like methadone or buprenorphine, these interventions explore the potential of physical activity and self-regulation techniques to manage addiction and pain. The unique feature of using stationary bikes, both assisted and voluntary, aims to improve physical health and mental well-being, potentially enhancing recovery outcomes. Psychotherapy like I-STOP offers a tailored approach to self-regulation, helping individuals better manage cravings and stress. This combination could offer a holistic alternative by addressing both physical and psychological aspects of addiction.

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

Research has shown that physical exercise, including self-chosen activities, can reduce cravings and improve overall health for people with substance use disorders. In this trial, participants may engage in voluntary exercise or assisted exercise, where a bike helps them pedal faster. Both exercise types have demonstrated benefits, such as reducing cravings and boosting mood.

Regarding therapy, some participants in this trial will receive the I-STOP program, which uses cognitive behavioral therapy. This approach has proven effective in reducing anxiety and improving treatment outcomes for opioid use disorder. Studies indicate that combining therapy with other treatments can be very effective for maintaining recovery. Overall, both exercise and therapy show promise in managing opioid use disorder. ^{1 2 4 5 6}

Who Is on the Research Team?

Nora L Nock, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

Adults aged 18-65 with an Opioid Use Disorder or Poly-substance Drug Use including opioids, enrolled in a residential drug treatment program. Participants must have chronic non-cancer pain and be medically cleared to exercise by the treatment center's staff.

Inclusion Criteria

Approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP))

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)

I am currently in a drug treatment program at a partner center.

Exclusion Criteria

Any substantive contraindications to exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 'assisted' rate cycling, voluntary rate cycling, and psychotherapy for pain individually and in combination as adjunctive treatments

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Psychotherapy

Trial Overview The trial is testing how 'assisted' rate cycling, voluntary rate cycling, and psychotherapy for pain (I-STOP) affect cravings in opioid users. It also looks at their impact on depression, anxiety, and sleep as secondary outcomes.

How Is the Trial Designed?

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

Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

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

Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. 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).

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

Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

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

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). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

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

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). 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).

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

Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).

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 Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Exercise training may significantly benefit individuals with alcohol use disorders (AUDs) by positively impacting mental health factors such as stress, anxiety, impulsivity, and depression.

The review highlights that exercise may enhance social interactions and boost self-efficacy, which can help reduce excessive alcohol consumption, suggesting a multifaceted approach to treating AUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training - A beneficial intervention in the treatment of alcohol use disorders? Stoutenberg, M., Rethorst, CD., Lawson, O., et al.[2022]

A pilot study involving 16 drug-dependent patients showed that a 12-week moderate-intensity aerobic exercise program is feasible and can be integrated into substance abuse treatment.

Participants who attended at least 75% of the exercise sessions had significantly better outcomes in terms of abstinence from drugs and alcohol, along with improved cardiorespiratory fitness, suggesting that exercise may enhance recovery efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Aerobic Exercise as an Adjunctive Treatment for Drug Dependence. Brown, RA., Abrantes, AM., Read, JP., et al.[2022]

In a study of 187 participants undergoing intensive outpatient treatment for substance use disorders, those who completed exercise-related activities (n=45) achieved longer durations of abstinence compared to those who did not exercise (n=142).

These results suggest that incorporating exercise into treatment plans for substance use disorders may enhance treatment outcomes and support longer periods of sobriety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-related activities are associated with positive outcome in contingency management treatment for substance use disorders. Weinstock, J., Barry, D., Petry, NM.[2022]

A study involving 97 patients in substance use recovery found that 71% were not currently exercising regularly, highlighting a significant gap in physical activity during early recovery.

Despite low current exercise rates, 95% of participants expressed interest in a tailored exercise program for recovery, indicating a strong desire to incorporate physical activity into their treatment plans, with preferences varying by gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EXERCISE PREFERENCES OF PATIENTS IN SUBSTANCE ABUSE TREATMENT. Abrantes, AM., Battle, CL., Strong, DR., et al.[2022]

Exercise can serve as an effective adjunctive intervention to opiate agonist treatments, potentially improving mood, quality of life, and reducing substance use among individuals with opiate dependence.

Implementing exercise interventions requires careful consideration of safety and adherence strategies to ensure that individuals can benefit from the physical and mental health advantages of regular exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as an adjunct treatment for opiate agonist treatment: review of the current research and implementation strategies. Weinstock, J., Wadeson, HK., VanHeest, JL.[2021]

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 high-intensity interval training (HIIT) program significantly reduced symptoms of depression, anxiety, and substance craving in 22 male inpatients with opioid use disorder, as measured by standardized scales before and after treatment.

The HIIT program also led to a notable increase in serum levels of insulin-like growth factor 1 (IGF-1) in the exercise group compared to the control group, indicating potential biological benefits, while cortisol, interferon-gamma, and interleukin 17 levels remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Effects of High Intensity Interval Training on Cytokine Levels and Clinical Course in Treatment of Opioid Use Disorder. Taş Dürmüş, P., Vardar, ME., Kaya, O., et al.[2022]

In the STRIDE trial involving individuals in substance use disorder treatment, males showed better adherence to prescribed exercise compared to females, completing more sessions and maintaining stable body mass index (BMI) and waist circumference, while females experienced increases in these measures over time.

The study highlights significant gender differences in physiological responses to exercise, suggesting that tailored exercise interventions may be necessary for effective treatment in substance use disorder programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study. Killeen, TK., Wolf, B., Greer, TL., 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]

Citations

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

Medication-Assisted Treatment FAQ ... outcomes. MAT helps treat opioid use disorder (OUD) by helping normalize brain chemistry, blocking the euphoric effects of opioids, and relieving physical ...

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

The Role of Physical Exercise in Opioid Substitution Therapy Based on these findings, the prevailing view is that physical exercise can be an effective alternative for addictive substances [98,100], ...

3. 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.

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

Opioid Use Disorder: Evaluation and Management - NCBI - NIH Opioid use disorder (OUD) is defined as the chronic use of opioids that causes clinically significant distress or impairment.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1755296624000152

Physical activity during a treatment for substance use ... According to participants (80% with opioid use disorder), the PA intervention reduced symptoms of craving, improved personal health, and provided a sense of ...

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

CDC Clinical Practice Guideline for Prescribing Opioids ... This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.