Divided or Single Exposure (DOSE) Study
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years of age or older
Currently receiving methadone for treatment of OUD for >90 days and have been consuming the same dose for >30 days
Have previously received a take-home dose of methadone as part of routine care
Willing to comply with study schedule
Disqualifiers
Pregnant
Presence of acute medical problem that requires immediate and intense medical management
Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits
Plans to leave methadone treatment during the study period
Trial design
Design model
Parallel
Treatments tested in this trial
Methadone (100% dose)
DrugMethadone for the treatment of opioid use disorder
Methadone (50% dose)
DrugMethadone for the treatment of opioid use disorder
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Treatment as Usual (TAU)Active comparator 1 intervention
Group B: Split-dosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Using the Brief Pain Inventory rating of "Worst Pain" in the past 24 hours, rated on a scale of 1-10, collected once weekly during weeks 1 through 12 of the intervention.
Time frame
Week 1 up to week 12Secondary outcomes
1
Change in Pain Tolerance Latency
Time in seconds (0-300) to removal of hand from cold pressor measure of laboratory-induced pain, collected point-prevalence during weeks 1, 6, and 12 of the intervention.
Time frame
Weeks 1, 6, and 122
Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score
Past 7 day Pain-related Disability Scale Total Score (range 0-70), collected once weekly during weeks 1 through 12 of the intervention.
Time frame
Week 1 up to 123
Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale
Past 24 hour total score (range 0-64) for the Subjective Opioid Withdrawal Scale (SOWS), collected once weekly during weeks 1 through 12 of the intervention.
Time frame
Week 1 up to 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov