Opiate Dependence
Conditions
Keywords
Methadone Treatment, Opiate dependence, Services research
Brief summary
The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.
Detailed description
Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.
Interventions
OTHERPatient-Centered Methadone Treatment
Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.
Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.
Sponsors
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* opiate dependence * newly admitted to methadone treatment
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opiate Positive Urine Tests | 12-months post-baseline | Number of participants with opiate positive urine tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cocaine Positive Urine Tests | 12-months post-baseline | Cocaine positive urine drug test |
| Drug Use HIV Risk Behavior | 12-months post-baseline | HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. |
| Criminal Behavior | 12-months post-baseline | Days of criminal behavior |
| Number of Participants Meeting DSM-IV Opiate Dependence Criteria | 12-months post-baseline | Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence |
| Number of Participants Meeting DSM-IV Cocaine Dependence Criteria | 12-months post-baseline | Number of participants meeting DSM-IV cocaine dependence criteria |
| Global Score on the World Health Organization Quality of Life Measure | 12-months post-baseline | Scale from 1 through 5. A higher score reflects a better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient-Centered Methadone Treatment Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.
Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event. | 146 |
| Methadone Treatment as Usual Methadone treatment provided as usual in the U.S.
Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic. | 149 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | withdrawn from study | 3 | 2 |
Baseline characteristics
| Characteristic | Patient-Centered Methadone Treatment | Methadone Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 10.3 | 42.0 years STANDARD_DEVIATION 9.8 | 42.7 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Black | 90 Participants | 81 Participants | 171 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 66 Participants | 122 Participants |
| Region of Enrollment United States | 146 participants | 149 participants | 295 participants |
| Sex: Female, Male Female | 54 Participants | 67 Participants | 121 Participants |
| Sex: Female, Male Male | 92 Participants | 82 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 146 | 4 / 149 |
| other Total, other adverse events | 0 / 146 | 0 / 149 |
| serious Total, serious adverse events | 31 / 146 | 36 / 149 |
Outcome results
Primary
Number of Participants With Opiate Positive Urine Tests
Number of participants with opiate positive urine tests
Time frame: 12-months post-baseline
Population: Missing data were counted as positive
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient-Centered Methadone Treatment | Number of Participants With Opiate Positive Urine Tests | 89 Participants |
| Methadone Treatment as Usual | Number of Participants With Opiate Positive Urine Tests | 90 Participants |
p-value: 0.92Mixed Models Analysis
Secondary
Criminal Behavior
Days of criminal behavior
Time frame: 12-months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-Centered Methadone Treatment | Criminal Behavior | 2.99 Number of Days in the Past 30 days | Standard Deviation 0.75 |
| Methadone Treatment as Usual | Criminal Behavior | 3.72 Number of Days in the Past 30 days | Standard Deviation 0.93 |
p-value: 0.54Mixed Models Analysis
Secondary
Drug Use HIV Risk Behavior
HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time frame: 12-months post-baseline
Population: Baseline values were used when 12 month data were missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-Centered Methadone Treatment | Drug Use HIV Risk Behavior | 0.72 units on a scale | Standard Deviation 2.56 |
| Methadone Treatment as Usual | Drug Use HIV Risk Behavior | 1.36 units on a scale | Standard Deviation 3.63 |
p-value: 0.08Mixed Models Analysis
Secondary
Global Score on the World Health Organization Quality of Life Measure
Scale from 1 through 5. A higher score reflects a better quality of life.
Time frame: 12-months post-baseline
Population: Baseline values were used when 12 month data were missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-Centered Methadone Treatment | Global Score on the World Health Organization Quality of Life Measure | 3.70 units on a scale | Standard Deviation 0.91 |
| Methadone Treatment as Usual | Global Score on the World Health Organization Quality of Life Measure | 3.47 units on a scale | Standard Deviation 1 |
p-value: 0.04Mixed Models Analysis
Secondary
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Number of participants meeting DSM-IV cocaine dependence criteria
Time frame: 12-months post-baseline
Population: Baseline values were used when 12 month data were missing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient-Centered Methadone Treatment | Number of Participants Meeting DSM-IV Cocaine Dependence Criteria | 41 Participants |
| Methadone Treatment as Usual | Number of Participants Meeting DSM-IV Cocaine Dependence Criteria | 52 Participants |
p-value: 0.21Mixed Models Analysis
Secondary
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Time frame: 12-months post-baseline
Population: Baseline values were used when 12 month data were missing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient-Centered Methadone Treatment | Number of Participants Meeting DSM-IV Opiate Dependence Criteria | 88 Participants |
| Methadone Treatment as Usual | Number of Participants Meeting DSM-IV Opiate Dependence Criteria | 103 Participants |
p-value: 0.11Mixed Models Analysis
Secondary
Number of Participants With Cocaine Positive Urine Tests
Cocaine positive urine drug test
Time frame: 12-months post-baseline
Population: Missing data were considered positive
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient-Centered Methadone Treatment | Number of Participants With Cocaine Positive Urine Tests | 67 Participants |
| Methadone Treatment as Usual | Number of Participants With Cocaine Positive Urine Tests | 85 Participants |
p-value: 0.06Mixed Models Analysis