Trial Outcomes & Findings for SMART Effectiveness Trial (NCT NCT04464421)
NCT ID: NCT04464421
Last Updated: 2025-12-05
Results Overview
Defined as no negative buprenorphine urine tests and attendance of at least two visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Through study completion, an average of 4 months
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Contingency management (CM)
Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Contingency management (CM)
Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
SMART Effectiveness Trial
Baseline characteristics by cohort
| Measure |
Contingency Management (CM)
n=22 Participants
Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
n=22 Participants
BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.45 years
STANDARD_DEVIATION 10.75 • n=9 Participants
|
35.41 years
STANDARD_DEVIATION 9.88 • n=6 Participants
|
37.43 years
STANDARD_DEVIATION 10.41 • n=9 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
26 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
42 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
27 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 monthsDefined as no negative buprenorphine urine tests and attendance of at least two visits.
Outcome measures
| Measure |
Contingency management (CM)
n=22 Participants
Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
n=22 Participants
BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
|---|---|---|
|
Treatment Adherence
|
16 Participants
|
13 Participants
|
Adverse Events
Contingency management (CM)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Contingency management (CM)
n=22 participants at risk
Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
Brief Motivational Intervention + Substance Free Activities + Mindfulness-Based Adherence Promotion
n=22 participants at risk
BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.
|
|---|---|---|
|
Social circumstances
Overdose
|
4.5%
1/22 • Number of events 1 • Participants were systematically assessed for adverse events throughout their participation in the study which lasted for 6 months from baseline.
Clinicaltrials.gov definitions were used.
|
0.00%
0/22 • Participants were systematically assessed for adverse events throughout their participation in the study which lasted for 6 months from baseline.
Clinicaltrials.gov definitions were used.
|
|
Surgical and medical procedures
Incomplete spinal fusion
|
0.00%
0/22 • Participants were systematically assessed for adverse events throughout their participation in the study which lasted for 6 months from baseline.
Clinicaltrials.gov definitions were used.
|
4.5%
1/22 • Number of events 1 • Participants were systematically assessed for adverse events throughout their participation in the study which lasted for 6 months from baseline.
Clinicaltrials.gov definitions were used.
|
Other adverse events
Adverse event data not reported
Additional Information
Karen Derefinko, PhD
University of Tennessee Health Science Center
Phone: 9014482526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place