Trial Outcomes & Findings for Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse (NCT NCT01967641)
NCT ID: NCT01967641
Last Updated: 2019-04-24
Results Overview
Retention was number of participants retained at study end (Week 19).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
week 19
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Buprenorphine/Naloxone Combination
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
Randomized
STARTED
|
51
|
|
Randomized
COMPLETED
|
43
|
|
Randomized
NOT COMPLETED
|
8
|
|
Admission to Inpatient Phase
STARTED
|
43
|
|
Admission to Inpatient Phase
COMPLETED
|
31
|
|
Admission to Inpatient Phase
NOT COMPLETED
|
12
|
|
12-week Outpatient Phase
STARTED
|
31
|
|
12-week Outpatient Phase
COMPLETED
|
18
|
|
12-week Outpatient Phase
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse
Baseline characteristics by cohort
| Measure |
Buprenorphine/Naloxone Combination
n=51 Participants
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucaisan
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
unknown
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 19Retention was number of participants retained at study end (Week 19).
Outcome measures
| Measure |
Buprenorphine/Naloxone Combination
n=51 Participants
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
Number of Participants Retained in Study
|
18 participants
|
SECONDARY outcome
Timeframe: at week 19 or length of study participationRelapse was number of participants with opioid-negative urine toxicology in last week of study participation.
Outcome measures
| Measure |
Buprenorphine/Naloxone Combination
n=31 Participants
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
Number of Participants Abstinent From Opioids
|
17 participants
|
SECONDARY outcome
Timeframe: assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.The primary pain measure was the Pain Assessment and Documentation Tool (PADT). Total score ranging from 0-11 reported. Higher score considered indicative of more pain. Lower score is indicative of less pain.
Outcome measures
| Measure |
Buprenorphine/Naloxone Combination
n=31 Participants
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
Pain Measurement
screening
|
6.1 units on a scale
Standard Deviation 1.9
|
|
Pain Measurement
end of study
|
4.3 units on a scale
Standard Deviation 0.65
|
Adverse Events
Buprenorphine/Naloxone Combination
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine/Naloxone Combination
n=51 participants at risk
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
|
|---|---|
|
General disorders
Hospitalization for rehydration/nutrition
|
2.0%
1/51
|
|
Psychiatric disorders
ER presentation for altered mental status after ingesting sleeping pills
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
2.0%
1/51
|
|
Cardiac disorders
chest pain
|
2.0%
1/51
|
|
General disorders
Somnolence, BP drop; intubated in ER;
|
2.0%
1/51
|
|
General disorders
leg pain/swelling
|
2.0%
1/51
|
|
Renal and urinary disorders
Urinary tract infection
|
2.0%
1/51
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Maria A. Sullivan, M.D., Ph.D
New York State Psychiatric Institute
Phone: 646-774-6152
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place