Trial Outcomes & Findings for Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II) (NCT NCT00929253)
NCT ID: NCT00929253
Last Updated: 2022-05-27
Results Overview
Abstinence defined as the longest documented period of continuous abstinence from opioids and cocaine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-05-27
Participant Flow
Participant milestones
| Measure |
Computer Delivered CRA + CM + Suboxone
In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for "homework" worksheets are provided. These participants receive vouchers for providing drug negative urine samples.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
CRA: Computer-delivered Community Reinforcement Approach
|
CM + Suboxone
In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer delivered CRA, only treatment as usual with a biweekly 30-minute meeting with a clinician.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Therapy: treatment as usual
CM: Contingency management (vouchers) for providing drug negative urine samples.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
79
|
|
Overall Study
COMPLETED
|
91
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II)
Baseline characteristics by cohort
| Measure |
Computer Delivered CRA + CM + Suboxone
n=91 Participants
In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for "homework" worksheets are provided. These participants receive vouchers for providing drug negative urine samples.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
CRA: Computer-delivered Community Reinforcement Approach
|
CM + Suboxone
n=79 Participants
In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer deliver therapy, only treatment as usual consisting of biweekly 30-minute counseling sessions.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Therapy: treatment as usual
CM: Contingency management (vouchers) for providing a drug negative urine sample.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
91 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
79 participants
n=7 Participants
|
170 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksAbstinence defined as the longest documented period of continuous abstinence from opioids and cocaine
Outcome measures
| Measure |
Computer Delivered CRA + CM + Suboxone
n=91 Participants
In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for "homework" worksheets are provided. These participants receive vouchers for providing drug negative urine samples.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
CRA: Computer-delivered Community Reinforcement Approach
|
CM + Suboxone
n=79 Participants
In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer deliver therapy.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Therapy: Therapist-delivered therapy
CM: Contingency management (vouchers) for providing a drug negative urine sample.
|
|---|---|---|
|
Abstinence
|
55.0 days
Standard Deviation 26.2
|
49.5 days
Standard Deviation 30.6
|
Adverse Events
Computer Delivered CRA + CM + Suboxone
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
CM + Suboxone
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Computer Delivered CRA + CM + Suboxone
n=91 participants at risk
In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potential use drug and skills to deal with those situations. In addition, skills for dealing with anxiety and anger are also provided. Videos are displayed that have examples of real-left situations. HIV/AIDS education is also provided. The program is interactive with the participant being required to answer short questions at the end of each module and prompts for "homework" worksheets are provided. These participants receive vouchers for providing drug negative urine samples.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
CRA: Computer-delivered Community Reinforcement Approach
|
CM + Suboxone
n=79 participants at risk
In this arm of the study, the participants receive vouchers for providing a drug negative urine sample. These participants, however, do not have computer delivered CRA, only treatment as usual with a biweekly 30-minute meeting with a clinician.
Suboxone: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
Therapy: treatment as usual
CM: Contingency management (vouchers) for providing drug negative urine samples.
|
|---|---|---|
|
General disorders
adverse event
|
62.6%
57/91 • Number of events 147
Adverse event data were collected throughout the clinical trial from 2007 to 2010. At the time of the conduct of the clinical trial, adverse events were monitored by specific type. At this time (over ten years after data collection and five years after publication of the data), specific details are not available.
|
69.6%
55/79 • Number of events 113
Adverse event data were collected throughout the clinical trial from 2007 to 2010. At the time of the conduct of the clinical trial, adverse events were monitored by specific type. At this time (over ten years after data collection and five years after publication of the data), specific details are not available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place