Trial Outcomes & Findings for Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment (NCT NCT01442493)
NCT ID: NCT01442493
Last Updated: 2017-12-29
Results Overview
Number of participants with opiate positive urine tests
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
12-months post-baseline
Results posted on
2017-12-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
151
|
|
Overall Study
COMPLETED
|
146
|
149
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
withdrawn from study
|
3
|
2
|
Baseline Characteristics
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Baseline characteristics by cohort
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
90 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
146 participants
n=5 Participants
|
149 participants
n=7 Participants
|
295 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-months post-baselinePopulation: Missing data were counted as positive
Number of participants with opiate positive urine tests
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Number of Participants With Opiate Positive Urine Tests
|
89 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 12-months post-baselinePopulation: Missing data were considered positive
Cocaine positive urine drug test
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Number of Participants With Cocaine Positive Urine Tests
|
67 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 12-months post-baselinePopulation: Baseline values were used when 12 month data were missing.
HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Drug Use HIV Risk Behavior
|
0.72 units on a scale
Standard Deviation 2.56
|
1.36 units on a scale
Standard Deviation 3.63
|
SECONDARY outcome
Timeframe: 12-months post-baselineDays of criminal behavior
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Criminal Behavior
|
2.99 Number of Days in the Past 30 days
Standard Deviation .75
|
3.72 Number of Days in the Past 30 days
Standard Deviation .93
|
SECONDARY outcome
Timeframe: 12-months post-baselinePopulation: Baseline values were used when 12 month data were missing
Scale from 1 through 5. A higher score reflects a better quality of life.
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Global Score on the World Health Organization Quality of Life Measure
|
3.70 units on a scale
Standard Deviation 0.91
|
3.47 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12-months post-baselinePopulation: Baseline values were used when 12 month data were missing
Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
|
88 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 12-months post-baselinePopulation: Baseline values were used when 12 month data were missing
Number of participants meeting DSM-IV cocaine dependence criteria
Outcome measures
| Measure |
Patient-Centered Methadone Treatment
n=146 Participants
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.
|
Methadone Treatment as Usual
n=149 Participants
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.
|
|---|---|---|
|
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
|
41 Participants
|
52 Participants
|
Adverse Events
Patient-Centered Methadone Treatment
Serious events: 31 serious events
Other events: 0 other events
Deaths: 2 deaths
Methadone Treatment as Usual
Serious events: 36 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Patient-Centered Methadone Treatment
n=146 participants at risk
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.
|
Methadone Treatment as Usual
n=149 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in Back, Hip, Jaw, Groin
|
2.1%
3/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Infections and infestations
Soft Tissue Infection
|
4.1%
6/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
2.7%
4/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
5/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
2.0%
3/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Surgical and medical procedures
Knee Surgery
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Nervous system disorders
Seizures
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Psychiatric disorders
Depression
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
2.7%
4/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Hypertension
|
2.7%
4/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Reproductive system and breast disorders
Fibroids
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Injury, poisoning and procedural complications
Trauma
|
2.1%
3/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Metabolism and nutrition disorders
Gout
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Endocrine disorders
Pancreatitis
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Immune system disorders
Lupus
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
General disorders
Dehydration
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Cardiac disorders
Chest Pain
|
2.1%
3/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Cardiac disorders
Angina
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Stroke
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Infections and infestations
HIV
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.4%
2/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
2.0%
3/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Reproductive system and breast disorders
Spontaneous abortion
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Pulmonary Embolism
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Endocrine disorders
Diabetes Mellitus
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Nervous system disorders
Altered Mental Status
|
0.68%
1/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.00%
0/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
1.3%
2/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Psychiatric disorders
Psychiatric Disorder Unspecified
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
2.0%
3/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Renal and urinary disorders
Kidney Infection
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Varices
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Injury, poisoning and procedural complications
Infected catheter
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Gastrointestinal disorders
Ulcer
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Vascular disorders
Edema
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Injury, poisoning and procedural complications
Poisoning of Unknown Origin and Type
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/146 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
0.67%
1/149 • 1 year
All Serious Adverse Events were considered unrelated to study participation.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place