Drug Dependence
Conditions
Keywords
opioid dependence, outpatient treatment, intensive outpatient treatment
Brief summary
The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly drug-free programs.
Detailed description
This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly drug-free programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.
Interventions
BEHAVIORALOutpatient
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
BEHAVIORALIntensive Outpatient
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* heroin-dependent adults * new admissions to buprenorphine outpatient treatment
Exclusion criteria
* pregnancy * acute medical or psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) | 6 months post-baseline |
Countries
United States
Participant flow
Recruitment details
New patients entering buprenorphine treatment at one of the two participating outpatient drug-free treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site.
Pre-assignment details
345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.
Participants by arm
| Arm | Count |
|---|---|
| Intensive Outpatient Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling. | 170 |
| Outpatient Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling. | 175 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | clinic readmission | 1 | 1 |
| Overall Study | discontinued site | 10 | 11 |
| Overall Study | Lost to Follow-up | 12 | 9 |
| Overall Study | non-African American participant | 13 | 6 |
| Overall Study | non-regular treatment track at clinic | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Outpatient | Intensive Outpatient | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 174 Participants | 168 Participants | 342 Participants |
| Age, Continuous | 46.27 years STANDARD_DEVIATION 6.75 | 44.15 years STANDARD_DEVIATION 8.15 | 45.23 years STANDARD_DEVIATION 7.53 |
| Region of Enrollment United States | 175 participants | 170 participants | 345 participants |
| Sex: Female, Male Female | 67 Participants | 62 Participants | 129 Participants |
| Sex: Female, Male Male | 108 Participants | 108 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Time frame: 6 months post-baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Outpatient | Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) | 20 percentage of opioid dependent subjects |
| Outpatient | Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) | 21 percentage of opioid dependent subjects |