Table 6.
Active Clinical Trials & Funded Research Studies.
| Title | PI |
|
Study Description | NCT ID/NIH Project Reporter Number/ Grant Number |
Anticipated Study Closure Date |
|---|---|---|---|---|---|
| Psychosocial/Behavioral Interventions | |||||
| Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings (TOPPS) | Stein M. |
|
This trial will examine a CBT intervention for patients in primary care buprenorphine treatment that addresses the relationship between pain, depression, substance misuse and functioning. The intervention incorporates psychoeducation about pain, depression and opioid misuse, patient coaching and a focus on acceptance. | NCT03698669 | August 2023 |
| Contingency Management to Enhance Office-Based Buprenorphine Treatment | Holtyn A. |
|
This study will compare the effectiveness of two Contingency Management interventions: "Buprenorphine Adherence and Opioid Abstinence" and "Buprenorphine Adherence Only" relative to a control group that will receive standard medical management alone. | NCT04024059 | December 2023 |
| Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder | Festinger D. |
|
This study will evaluate the effectiveness of two adjunctive psychosocial treatments provided within the context of office-based buprenorphine treatment, Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists/ Certified Peer Specialists. It seeks to identify which psychosocial interventions are most efficacious and what patient characteristics may inform the choice of intervention. | NCT04257214 | April 2023 |
| SMART Trial Efficacy Study | Derefinko K. |
|
This pilot study will compare Contingency Management (CM) therapy and a brief Motivational Intervention plus Substance Free Activities Session plus Mindfulness-based Adherence Promotion (BMI + SFAS + MBAP). | NCT04464421 | April 2021 |
| SMART Trial for Medication Assisted Treatment Adherence | Derefinko K. |
|
This study will compare the effectiveness of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Intervention plus Substance Free Activities Session (BMI + SFAS). | NCT04080180 | August 2021 |
| Integrating Support Persons Into Recovery (INSPIRE) | Osilla K. |
|
Integrated Support Persons Into Recovery (INSPIRE) will test whether integrating a patient’s support person into patients’ buprenorphine treatment can improve outcomes. The treatment approach utilized will be Community Reinforcement and Family Training (CRAFT). | NCT04239235 | July 2023 |
| Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (Persist) | Lin A., Ilgen M. |
|
Buprenorphine prescribed patients with comorbid chronic pain will be enrolled in a program that focuses on educational information and pain management strategies. | NCT04433975 | July 2025 |
| MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment | Schuman-Olivier Z. |
|
This study will refine a mindfulness intervention paired with group-based opioid treatment to be utilized within the primary care context. The intervention is designed to address stress, anxiety, depression, pain and addiction recovery. | NCT03798431 | February 2020 |
| Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase) (Mindful-OBOT) | Schuman-Olivier Z. |
|
This is a multi-site randomized comparative effectiveness trial comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to standard Group-based Opioid Treatment (GBOT). The main outcome will be abstinence, with anxiety measures and treatment retention included as secondary outcomes. | NCT04278586 | December 2021 |
| Technological Interventions | |||||
| Digital Health Intervention for Medication-Assisted Treatment (iCOPE) | Langdon K. |
|
This study will develop a distress tolerance training intervention delivered via interactive computer and text message, the goal of which is to support patients in managing physical and emotional distress. | NCT03842384 | August 2021 |
| Improving Office Based Treatment of Opioid Use Disorder With Technology | Gordon M. |
|
This study will examine the effectiveness of a smart medication dispensing system and associated on-line platform, BupreCare, compared to treatment as usual or a medication event monitoring system pill bottle, which tracks when the bottle is opened and closed. | NCT03586466 | September 2020 |
| Buprenorphine Treatment Engagement and Overdose Prevention | Hampton J. |
|
This study will utilize Video Directly Observed Therapy, along with an incentive structure, to increase medication adherence among buprenorphine-naloxone prescribed individuals. | NCT03677986 | October 2023 |
| MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence | Schuman-Olivier Z. |
|
This study will evaluate the MySafeRx system, which combines medication adherence through supervised medication administration with recovery supports such as motivational interviewing and electronically delivered reminders. | NCT02778282 | March 2021 |
| Remote Observed Dosing of Suboxone to Improve Clinical Practice | Curti B. |
|
This study will examine whether remote observation of medication dosing via smartphone by clinicians will increase medication adherence in patients receiving buprenorphine for OUD. | NCT03769025 | December 2022 |
| Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth (Bundling) | Gustafson D. |
|
This study will examine the impact on long-term opioid use of medication-assisted treatment (MAT) bundled with an evidence-based mobile-health system (A-CHESS), which includes interactive modules, education, community resources, and a means to communicate with addiction experts and the health team. | NCT02712034 | January 2020 |
| Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App | Kawasaki S. |
|
This study will examine whether an app based cognitive behavior therapy, reSET, improves adherence and outcomes for patients diagnosed with OUD and receiving office-based buprenorphine. | NCT03826966 | January 2021 |
| Adapting Web-based CBT to Improve Adherence and Outcomes for Individuals with Opioid Use Disorder and Chronic Pain Treated with Opioid Agonists | Carroll K. |
|
This study will develop and pilot test an integrated, web-based cognitive behavioral approach to the treatment of chronic pain and opioid use disorder, and evaluate its efficacy relative to standard care among a diverse sample of individuals with chronic pain treated with buprenorphine or methadone. | 1R61AT010619 | February 2022 |
| Effectiveness of a CBT-based Mhealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use | Glasner-Edwards S. |
|
This study will examine a text messaging intervention, Interactive Messaging for Freedom from Opioid Addiction (imFREE), that expands upon a previous study that developed a cognitive behavioral therapy-based short message system intervention, TXT-CBT. | 1R61AT010800 | February 2021 |
| Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes | Ilgen M. |
|
This study will develop a telephone-based psychosocial pain management intervention, incorporating educational information and strategies for pain and medication management, and measure its efficacy in treating OUD adjunctively with MAT. | 4R33AT010106 | September 2021 |
| Enhancing the Impact of Behavioral Pain Management on MAT Outcomes | Ilgen M. |
|
This study will examine the efficacy of a previously developed telephone-based psychosocial pain management intervention. Follow up assessments will extend long term outcome measures and incorporate qualitative feedback gathered from MAT providers and other stakeholders. | 1R01AT010797 | August 2023 |
| A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder | Imbert B. |
|
This study will develop a mobile app (reSET-O+) to assist adherence through contingency management, as well as facilitate home induction of buprenorphine via self-monitoring and support tools. | 1R44DA049493 | August 2021 |
| Non-Invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving During Treatment of Opioid Use Disorder | Jaasma M. |
|
This study will examine the efficacy of a non-invasive transcutaneous electrical nerve stimulation via the EMPOWER Nueuromodulation System. | 1R43DA049623 | August 2021 |
| Complementary Interventions | |||||
| Mindful Moms in Recovery: Yoga-Based Mindfulness Relapse Prevention for Pregnant Women with Opioid Disorder | Lord S. | ? ? |
This study will develop a trauma-informed yoga and mindfulness-based relapse prevention protocol for pregnant and post-partum women. | 1R21AT010117 | September 2019 |
| Mindful Body Awareness With Buprenorphine for Opioid Use Disorder Treatment | Price C. |
|
This study seeks to evaluate the effectiveness of Mindful Awareness in Body-oriented Therapy as an adjunctive to standard buprenorphine treatment. | NCT04082637 | August 2023 |
| Pharmacologic Interventions | |||||
| Adjunctive Effects of Psilocybin and Buprenorphine | Brown R. |
|
This study will examine the safety of prescribed psilocybin among patients treated for OUD with buprenorphine. "Safety" will be measured by certain psychological measures and validated clinical and self-reported measures. Two doses of psilocybin will be administered under supervision and guidance (second dose is optional). | NCT04161066 | November 2021 |
| Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine (CURB) | Suzuki J. |
|
This study will determine the feasibility of cannabidiol as an adjunctive treatment to buprenorphine for OUD. | NCT04192370 | December 2021 |
*
Studies not registered in the National Registry of Clinical Trials are listed by NIH study designation.