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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Centered Methadone Treatment | Experimental | 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. |
|
| Methadone Treatment as Usual | Active Comparator | Methadone treatment provided as usual in the U.S. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Centered Methadone Treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Opiate Positive Urine Tests | Number of participants with opiate positive urine tests | 12-months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cocaine Positive Urine Tests | Cocaine positive urine drug test | 12-months post-baseline |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Schwartz, M.D. | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutes for Behavior Resources REACH | Baltimore | Maryland | 21218 | United States | ||
| University of Maryland Drug Treatment Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29536342 | Derived | Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Opiate Positive Urine Tests | Number of participants with opiate positive urine tests | Missing data were counted as positive | Posted | Count of Participants | Participants | 12-months post-baseline |
|
1 year
All Serious Adverse Events were considered unrelated to study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in Back, Hip, Jaw, Groin | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Schwartz, M.D. | Friends Research Institute | 410-837-3977 | 276 | rschwartz@friendsresearch.org |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Methadone Treatment as usual | Other | 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. |
|
| 12-months post-baseline |
| Criminal Behavior | Days of criminal behavior | 12-months post-baseline |
| 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. | 12-months post-baseline |
| Number of Participants Meeting DSM-IV Opiate Dependence Criteria | Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence | 12-months post-baseline |
| Number of Participants Meeting DSM-IV Cocaine Dependence Criteria | Number of participants meeting DSM-IV cocaine dependence criteria | 12-months post-baseline |
| Baltimore |
| Maryland |
| 21223 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
|
| Secondary | Number of Participants With Cocaine Positive Urine Tests | Cocaine positive urine drug test | Missing data were considered positive | Posted | Count of Participants | Participants | 12-months post-baseline |
|
|
|
|
| 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. | Baseline values were used when 12 month data were missing. | Posted | Mean | Standard Deviation | units on a scale | 12-months post-baseline |
|
|
|
|
| Secondary | Criminal Behavior | Days of criminal behavior | Posted | Mean | Standard Deviation | Number of Days in the Past 30 days | 12-months post-baseline |
|
|
|
|
| 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. | Baseline values were used when 12 month data were missing | Posted | Mean | Standard Deviation | units on a scale | 12-months post-baseline |
|
|
|
|
| Secondary | Number of Participants Meeting DSM-IV Opiate Dependence Criteria | Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence | Baseline values were used when 12 month data were missing | Posted | Count of Participants | Participants | 12-months post-baseline |
|
|
|
|
| Secondary | Number of Participants Meeting DSM-IV Cocaine Dependence Criteria | Number of participants meeting DSM-IV cocaine dependence criteria | Baseline values were used when 12 month data were missing | Posted | Count of Participants | Participants | 12-months post-baseline |
|
|
|
|
| 2 |
| 146 |
| 31 |
| 146 |
| 0 |
| 146 |
| EG001 | 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. | 4 | 149 | 36 | 149 | 0 | 149 |
| Soft Tissue Infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Knee Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Seizures | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Fibroids | Reproductive system and breast disorders | Systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pancreatitis | Endocrine disorders | Systematic Assessment |
|
| Lupus | Immune system disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| HIV | Infections and infestations | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spontaneous abortion | Reproductive system and breast disorders | Systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Diabetes Mellitus | Endocrine disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| Psychiatric Disorder Unspecified | Psychiatric disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Kidney Infection | Renal and urinary disorders | Systematic Assessment |
|
| Varices | Vascular disorders | Systematic Assessment |
|
| Infected catheter | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Edema | Vascular disorders | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
|
| Poisoning of Unknown Origin and Type | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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