Divided or Single Exposure (DOSE) Study

Status Recruiting

Clinical Trial Summary

This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

Clinical Trial Description

This study follows a successfully completed project (NCT03254043) to now pursue the investigators overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (OUD) among persons receiving methadone for the treatment of OUD. Up to 62% of persons maintained on methadone for OUD experience clinically significant pain, versus 31% in the general population. Pain in methadone-maintained persons (MMP) is associated with poor OUD treatment outcomes and severe distress. No effective treatment for comorbid pain and OUD currently exists; though preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. This study will evaluate an intervention for comorbid chronic pain among MMP using a Phase II double-blind, randomized, placebo-controlled comparison of treatment as usual (TAU) versus split daily methadone dosing for 12-weeks. Methadone will be remotely managed via an electronic pillbox. Outcomes will include weekly assessments of pain and OUD outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. If effective, this approach could transform the care of MMP with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. Results could provide a high magnitude treatment for the substantial number of MMP who experience daily pain with no reliable form of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05459402
Study type	Interventional
Source	Johns Hopkins University
Contact	Kelly E Dunn, PhD, M.B.A.
Phone	410-550-2254
Email	kdunn9@jhmi.edu
Status	Recruiting
Phase	Phase 2
Start date	February 21, 2023
Completion date	October 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01659073` - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation	N/A
Recruiting	`NCT05914311` - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration	N/A
Recruiting	`NCT05422456` - The Turkish Version of Functional Disability Inventory
Enrolling by invitation	`NCT05422443` - The Turkish Version of Pain Coping Questionnaire
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04385030` - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury	N/A
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05103319` - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed	`NCT03687762` - Back on Track to Healthy Living Study	N/A
Completed	`NCT04171336` - Animal-assisted Therapy for Children and Adolescents With Chronic Pain	N/A
Completed	`NCT03179475` - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury	Phase 4
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Recruiting	`NCT06204627` - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain	N/A
Recruiting	`NCT06060028` - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Terminated	`NCT03538444` - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder	N/A
Not yet recruiting	`NCT05812703` - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain