Exercise + Psychotherapy for Opioid Use Disorder
(EXPO-R33 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
Disqualifiers: Exercise contraindications, Psychiatric instability, Pregnancy, others
Stay on your current meds
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
13678How 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.
13479Eligibility Criteria
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 between 18 and 65 years old.
+2 more
Exclusion Criteria
Any substantive contraindications to exercise
Trial Timeline
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
Participant Groups
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.
6Treatment groups
Experimental Treatment
Active Control
Group I: Voluntary Exercise and No I-STOPExperimental Treatment1 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-STOPExperimental Treatment2 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-STOPExperimental Treatment1 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-STOPExperimental Treatment1 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-STOPExperimental Treatment2 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-STOPActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado at DenverDenver, CO
Case Western Reserve UniversityCleveland, OH
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Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
University of Colorado, DenverCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. [2022]Exercise may be a valuable adjunct therapy for individuals with opioid use disorder (OUD) due to its known benefits in brain health, sleep, overall quality of life, and reduced anxiety and depression. Additionally, physical activity may mitigate the experience of pain, leading to better control of chronic pain. The purpose of this scoping review was to evaluate the evidence to support physical activity (which includes exercise) interventions for individuals with OUD. Systematic searches were conducted by a librarian in September 2021 in PubMed, PsycINFO, EMBASE, Web of Science, Cochrane CENTRAL, and clinicaltrials.gov. Two reviewers independently screened titles and abstracts to reduce risk of bias. A total of 13 studies met inclusion criteria. Ten publications presented data specifically studying a physical activity intervention for OUD. Three studies provided retrospective data on the exercise experience and attitudes. Results indicated different exercise modalities led to positive outcomes related to immune function, reduction of pain, cravings, anxiety and depression, as well as improvements in mood and quality of life. Additionally, participants noted exercise as an acceptable and feasible adjunct treatment. Exercise may be a valuable adjunct therapy for individuals with OUD; however, the majority of the published literature consisted of small samples presenting an opportunity for future investigators to corroborate findings with larger sample sizes, utilizing different exercise modalities in different populations of patients with OUD.
A Pilot Study of Aerobic Exercise as an Adjunctive Treatment for Drug Dependence. [2022]Intervention to increase exercise in drug dependent patients represents a potentially useful yet unexplored strategy for preventing relapse. However, there are currently no established exercise interventions for use with this population. The purpose of this pilot study was to examine the feasibility of aerobic exercise as an adjunct to substance abuse treatment among drug dependent patients. Participants included 16 (31% female, 38.3 years old) drug dependent patients who participated in a 12-week, moderate-intensity aerobic exercise intervention. Participants attended a mean of 8.6 sessions (out of 12). Participants demonstrated a significant increase in percent days abstinent for both alcohol and drugs at the end of treatment, and those who attended at least 75% of the exercise sessions had significantly better substance use outcomes than those who did not. In addition, participants showed a significant increase in their cardiorespiratory fitness by the end of treatment. While preliminary, this study is one of the first to demonstrate the feasibility of incorporating aerobic exercise during drug abuse treatment. Future randomized control trials are a necessary next step to test the efficacy of a moderate-intensity aerobic exercise intervention as an adjunct to drug abuse treatment in this patient population.
The Role of Physical Activity in Opioid Substitution Therapy: A Systematic Review of Interventional and Observational Studies. [2022]Use of physical activity in the treatment and follow-up of people receiving opioid substitution therapy is an understudied area of research. Therefore, the objective of this systematic review was to synthesize the currently available research on the role of physical activity in opioid substitution therapy and proper adaptions for the group.
Exercise-related activities are associated with positive outcome in contingency management treatment for substance use disorders. [2022]Exercise has been proposed as an adjunct intervention for substance use disorders due to its many benefits in terms of mental and physical health. This study investigated the association between completion of exercise-related activities and substance use disorders treatment outcome in a sample of 187 participants undergoing intensive outpatient treatment with contingency management. The sample was divided into two groups based upon whether or not an individual completed an exercise-related activity. Individuals who engaged in exercise-related activities (n=45) were found to achieve longer durations of abstinence during treatment than individuals who did not complete an exercise-related activity (n=142). Overall, these findings suggest that exercise may be of benefit to individuals undergoing substance use disorders treatment. Methods for implementing an exercise intervention within substance use disorders treatment are discussed.
EXERCISE PREFERENCES OF PATIENTS IN SUBSTANCE ABUSE TREATMENT. [2022]While emerging studies have demonstrated the benefit of exercise in early recovery from substance use disorders, recruitment and adherence to exercise interventions have been challenging. Tailoring interventions based on patient exercise preferences may address these concerns. Ninety-seven (N=97; age=41.6 years; 44% female) patients were recruited from an intensive substance abuse outpatient program and filled out questionnaires about their exercise preferences. Most (71%) patients were not currently engaged in an exercise program (i.e., exercising less than 20 minutes/day for 3 days/week over the last 6 months). The vast majority (95%) expressed an interest in engaging in an exercise program specifically designed for persons in substance use recovery and 89% reported wanting to initiate an exercise program within the first 3 months of sobriety. Specific exercise preferences regarding type of physical activity, exercise intervention components, and perceived benefits and barriers to exercise differed between males and females. These findings suggest low rates of regular exercise, high level of interest in engaging in exercise during early recovery, and point toward the need to tailor interventions to the unique preferences of individuals.
Exercise training - A beneficial intervention in the treatment of alcohol use disorders? [2022]A growing body of evidence suggests that exercise training may have multiple beneficial effects in individuals with mental health or substance use disorders. Yet, relatively little knowledge exists regarding the benefits of exercise training to augment treatment for alcohol use disorders (AUDs).
Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study. [2023]Exercise may be beneficial for individuals in substance use disorder (SUD) treatment given the higher rates of both medical and psychiatric comorbidity, namely mood and anxiety disorders, compared to the general population. Gender and/or racial/ethnic differences in health benefits and response to prescribed exercise have been reported and may have implications for designing exercise interventions in SUD programs.
Evaluation of the Effects of High Intensity Interval Training on Cytokine Levels and Clinical Course in Treatment of Opioid Use Disorder. [2022]Opioid use disorder (OpUD) is a biological and psychosocial disorder with limited treatment options. Addition of physical exercise to the pharmacological treatment has been proposed to be effective on reducing substance use and improving the quality of life. In this study we aimed to investigate the effects of a high-intensity interval training (HIIT) program on the serum levels of cortisol, insulin-like growth factor1 (IGF-1), interferon-gamma (IFN-γ), interleukin 17 (IL-17) and the clinical progress of inpatients with OpUD.
Exercise as an adjunct treatment for opiate agonist treatment: review of the current research and implementation strategies. [2021]Opiate dependence is a significant public health concern linked to poor quality of life, comorbid psychiatric disorders, and high costs to society. Current opiate agonist treatments are an effective but limited intervention. Adjunctive interventions could improve and augment opiate agonist treatment outcomes, including drug abstinence, quality of life, and physical health. This article reviews exercise as an adjunctive intervention for opiate agonist treatment, especially in regards to improving mood and overall quality of life, while reducing other substance use. Poor adherence and dropout frequently prevent many individuals from garnering the many physical and mental health benefits of exercise. Strategies for implementing an exercise intervention, including safety considerations, are discussed.