Supervised Exercise for Opioid Use Disorder

(HELM Trial)

Overseen By Danielle Jake-Schoffman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Opioid maintenance

Disqualifiers: Heart disease, Stroke, Uncontrolled diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supervised aerobic exercise program can aid individuals with Opioid Use Disorder (OUD). Participants will engage in a 12-week program with three weekly walking sessions to determine if regular exercise supports recovery. It targets those currently in opioid treatment or with mild OUD who exercise infrequently (less than 20 minutes, three times a week). Participants must be willing to visit the research center once a week for 12 weeks. The goal is to assess if exercise can effectively manage OUD. As an unphased trial, this study provides a unique opportunity to explore innovative recovery support through exercise.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be on opioid maintenance treatment or have mild opioid use disorder, it seems likely that you can continue your current medications.

What prior data suggests that this supervised exercise intervention is safe for individuals with Opioid Use Disorder?

Research has shown that supervised exercise is usually safe and well-tolerated. In a study involving people undergoing opioid treatment, structured exercise improved fitness levels without major safety concerns. Aerobic exercise, such as walking, is also known to reduce anxiety and cravings, which can benefit those with opioid use disorder.

One study found that aerobic activity reduced substance use in animals, suggesting it might help humans as well. Another study discovered that people using substances felt exercise could replace the 'high' they sought from drugs.

While these findings are promising, exercise programs for opioid use disorder are still under study for safety and effectiveness. However, aerobic exercise, like walking, is generally considered a low-risk activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for opioid use disorder, which often involve medication-assisted therapies like methadone or buprenorphine, the supervised exercise intervention focuses on physical activity as a form of therapy. This approach is unique because it harnesses the benefits of regular exercise, such as improving mental health and reducing cravings, without relying on pharmaceuticals. Researchers are excited about this treatment as it offers a holistic and potentially less stigmatizing way to support recovery, encouraging a healthier lifestyle that might enhance overall well-being and complement existing treatments.

What evidence suggests that supervised exercise might be an effective treatment for Opioid Use Disorder?

Research has shown that aerobic exercise might help people with opioid use disorder (OUD) by reducing cravings and improving health. In one study, participants reported that physical activity lessened their cravings and made them feel healthier. Another study suggested that adding exercise to opioid treatment can improve fitness. In animals, aerobic exercise reduced the use of opioids like morphine and heroin, indicating it might help decrease dependence. While the evidence is promising, more research is needed to fully understand exercise's effectiveness for OUD. Participants in this trial will engage in a supervised exercise intervention to further explore these potential benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Meredith S Berry, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults aged 21-64 with mild to severe Opioid Use Disorder, who are not very active physically and can visit the research center weekly for 12 weeks. They must be able to exercise safely as determined by a medical exam. Pregnant individuals, those in other exercise or weight loss programs, or with certain medical conditions like heart disease or uncontrolled diabetes cannot join.

Inclusion Criteria

I can visit the research center weekly for 3 months.

Body mass index 18.5-40 kg/m^2

I am between 21 and 64 years old.

Exclusion Criteria

I have a heart condition, stroke history, uncontrolled diabetes, thyroid issues, or an eating disorder.

Uncontrolled major psychiatric condition (e.g., schizophrenia; conditions that are well-controlled, however [e.g., anxiety controlled through therapy] will not be exclusionary), or other medical condition(s) that contraindicate exercise; and may not be participating in a structured exercise training or weight loss program

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Baseline Assessment

Participants undergo baseline assessment before starting the intervention

1 week

Treatment

Participants engage in a 12-week supervised aerobic exercise program, completing 3 walking sessions per week

12 weeks

1 in-person visit per week, 2 optional off-site sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Supervised Exercise Intervention

Trial Overview

The study tests a supervised aerobic exercise program over 12 weeks to see if it helps people with Opioid Use Disorder. Participants will engage in regular physical activity under supervision and their progress will be monitored throughout the program.

How Is the Trial Designed?

Group I: Supervised Exercise Intervention Experimental Treatment 1 Intervention

Participants will be asked to complete 3 walking sessions per week for 12 weeks. We will ask them to complete at least 1 of these sessions in-person on-site and they will be given the option to complete up to 2 walking sessions per week off-site. Exercise training on-site will be performed on an indoor walking path, 50 min/session (plus 5 min. for each warm-up and cool down).

Supervised Exercise Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Supervised Exercise Therapy for:

• Peripheral Artery Disease
• Symptomatic Peripheral Artery Disease
• Opioid Use Disorder (as part of comprehensive treatment)

Approved in European Union as Supervised Exercise Programme for:

• Peripheral Arterial Disease
• Cardiovascular Rehabilitation
• Chronic Conditions Management

Approved in Canada as Exercise Therapy for:

• Cardiovascular Health
• Chronic Disease Management
• Mental Health Support

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a study of 193 obese participants over 18 months, various strategies to enhance exercise adherence were tested, with personal trainers and monetary incentives showing the best results for attendance at supervised walks.

Despite improved attendance with these strategies, they did not lead to higher overall energy expenditure or better long-term weight loss, suggesting that the recommended levels of exercise for effective weight loss may need to be significantly increased.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. Jeffery, RW., Wing, RR., Thorson, C., 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]

This study involves 39 patients with substance use disorders and aims to compare the psychological effects of soccer and circuit training against a non-exercise control group, assessing changes in mood, craving, and anxiety over time.

The researchers expect that both types of exercise will lead to greater psychological improvements compared to the control group, providing valuable insights into how accessible physical activities can aid in treating substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Acute Exercise on Drug Craving, Self-Esteem, Mood, and Affect in Adults with Polysubstance Use Disorder: Protocol for a Multicenter Randomized Controlled Trial. Ellingsen, MM., Johannesen, SL., Martinsen, EW., et al.[2020]

Regular exercise is essential for maintaining physical fitness and health in adults, with the American College of Sports Medicine recommending at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity cardiorespiratory exercise per week, along with resistance and flexibility training.

Even those who cannot meet the recommended exercise targets can still gain health benefits from engaging in any amount of physical activity, and strategies such as reducing sedentary time and incorporating enjoyable exercise can enhance adherence to exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Garber, CE., Blissmer, B., Deschenes, MR., 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]

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]

In a randomized controlled trial involving 31 morbidly obese participants, both aerobic training (AT) and resistance training (RT) significantly improved health-related fitness measures compared to a control group, including enhancements in walking distance, skin-fold thickness, and psychological factors like self-efficacy.

RT showed additional benefits over the control group in reducing BMI and waist circumference, indicating that while both exercise types are effective, resistance training may offer extra advantages in certain anthropometric measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 12 weeks supervised exercise in obesity management. Herring, LY., Wagstaff, C., Scott, A.[2015]

A 20-minute session of vigorous aerobic exercise significantly reduced heroin cravings in male addicts, showing effects during and up to 40 minutes after exercise, compared to a control group that rested.

The study also found that acute exercise improved inhibitory control, as evidenced by better performance on a Go/No-Go task, indicating that exercise may enhance cognitive functions related to addiction management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Aerobic Exercise Ameliorates Cravings and Inhibitory Control in Heroin Addicts: Evidence From Event-Related Potentials and Frequency Bands. Wang, D., Zhu, T., Chen, J., et al.[2022]

Physical exercise can serve as an effective alternative habit to help replace substance use in individuals with opioid and amphetamine dependence, with a focus on improving mood and reducing cravings.

Both opioid and amphetamine rehabilitation programs primarily utilize aerobic exercise, and while there are no significant differences in exercise frequency or duration between the two, the interventions aim to cultivate long-term exercise habits as a means of supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Exercise Intervention Program for People With Substance Use Disorder. Zhang, Z., Liu, X.[2023]

An 8-week exercise intervention showed promise in reducing methamphetamine (MA) use among lower severity users (those using MA for up to 18 days in the month before treatment), with these individuals reporting fewer days of use and lower positive urine test results compared to those in a health education control group.

While the exercise intervention did not significantly reduce MA use overall for all participants, it suggests that incorporating exercise may be beneficial specifically for individuals with lower severity of MA dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an exercise intervention on methamphetamine use outcomes post-residential treatment care. Rawson, RA., Chudzynski, J., Mooney, L., 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 supervised physical activity program for individuals with type 2 diabetes or obesity resulted in a significantly lower attrition rate (28%) compared to a self-selected program (45%), suggesting better adherence to structured exercise.

Both programs led to similar improvements in body weight and physical fitness, but the supervised program may offer long-term benefits due to its lower dropout rates, indicating that initial supervision could enhance overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised vs. self-selected physical activity for individuals with diabetes and obesity: the Lifestyle Gym program. Mazzuca, P., Montesi, L., Mazzoni, G., et al.[2018]

In a 12-week weight-reduction program involving 30 obese women, those who engaged in aerobic exercise (EX group) showed better dietary compliance compared to those who did not exercise (NX group).

The EX group had a smaller discrepancy between their actual energy intake and prescribed intake, indicating that aerobic exercise may enhance adherence to dietary restrictions, which is crucial for effective weight loss in moderate obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise enhances dietary compliance during moderate energy restriction in obese women. Racette, SB., Schoeller, DA., Kushner, RF., et al.[2018]

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