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 work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety 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's best to discuss this with the trial coordinators or your doctor.

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

Exercise is generally considered safe for individuals with opioid use disorder and may improve mood, reduce anxiety and depression, and enhance overall quality of life. Participants in studies have found exercise to be an acceptable and feasible part of their treatment. ^{1 2 3 4 5}

How does the Exercise + Psychotherapy treatment for Opioid Use Disorder differ from other treatments?

This treatment is unique because it combines exercise with psychotherapy, which may improve brain health, sleep, and overall quality of life while reducing anxiety, depression, and pain. Unlike standard drug treatments, this approach uses physical activity as an adjunct therapy to enhance the benefits of traditional opioid use disorder treatments. ^{1 2 4 6 7}

What data supports the effectiveness of this treatment for opioid use disorder?

Research shows that exercise can improve brain health, sleep, and overall quality of life for people with opioid use disorder, and it may help reduce anxiety, depression, and cravings. Additionally, studies suggest that exercise can lead to longer periods of abstinence in substance use disorder treatments. ^{1 2 6 8 9}

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

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)

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

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 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 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]

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 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 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]

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]

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]

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]

Citations

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

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

2. England pubmed.ncbi.nlm.nih.gov

A Pilot Study of Aerobic Exercise as an Adjunctive Treatment for Drug Dependence. [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

Exercise-related activities are associated with positive outcome in contingency management treatment for substance use disorders. [2022]

5. England pubmed.ncbi.nlm.nih.gov

EXERCISE PREFERENCES OF PATIENTS IN SUBSTANCE ABUSE TREATMENT. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Exercise training - A beneficial intervention in the treatment of alcohol use disorders? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study. [2023]

8. Turkey 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. [2022]

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

Exercise as an adjunct treatment for opiate agonist treatment: review of the current research and implementation strategies. [2021]