Clinical trial NCT04080180: SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence
Official title: Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: opioid use disorder
buprenorphine
treatment adherence
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: University of Memphis
name: University of New Mexico
name: University of Tennessee
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-09-06
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In stage 1, participants are individually randomized (1:1) to BSM or CM. At the end of stage 1, adherent buprenorphine-naloxone participants remain in their respective intervention group during phase 2 (maintenance phase of same approach), whereas non-adherent participants are randomized (individually and 1:1) to either switch or add the respective other intervention in this part-factorial SMART. Our primary outcome is buprenorphine-naloxone adherence by the end of stage 2. This sequential randomization based on past treatment success assures that the assigned treatment option at any point in time is independent of future potential outcomes and only conditional on the subject's history, i.e., the sequential ignorable treatment assumption is satisfied by design,108 in sharp distinction to observational data where patients chose to switch/add or not to switch/add and where this assumption remains untestable.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM).

Detailed description: The investigators seek to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BSM adherence approaches, then conducting a Sequential Multiple Assignment Randomized Trial (SMART) to assess sequential, individual, and combined effects across MAT initiation and maintenance.

In order to tailor treatment to individual's needs, the study will follow a sequential multiple assignment randomized trial (SMART) design: In stage 1, participants are individually randomized (1:1) to BSM or CM. Adherent buprenorphine-naloxone participants complete treatment in the arm they were originally assigned to, but non-adherent participants are re-randomized (1:1) to either switch to the other intervention or add the other intervention in this part-factorial SMART.

Eligibility criteria: Inclusion Criteria:

* Present with symptoms of Opioid Use Disorder
* Eligible of receipt of buprenorphine-naloxone medication as determined by Study Doctor
* Access to a telephone

Exclusion Criteria:

* Under 18 years old
* Unable to understand spoken English

Primary outcomes:
measure: Medication-Assisted Treatment (MAT) Adherence
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References: