Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01442493
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 150
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Other: Patient-Centered Methadone Treatment; Other: Methadone Treatment as usual	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reengineering Methadone Treatment: A Randomized Clinical Trial
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: Methadone Treatment as Usual Methadone treatment provided as usual in the U.S.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Opiate Positive Urine Tests [12-months post-baseline]

   Number of participants with opiate positive urine tests

Secondary Outcome Measures

1. Number of Participants With Cocaine Positive Urine Tests [12-months post-baseline]

   Cocaine positive urine drug test

2. 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.

3. Criminal Behavior [12-months post-baseline]

   Days of criminal behavior

4. 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.

5. Number of Participants Meeting DSM-IV Opiate Dependence Criteria [12-months post-baseline]

   Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence

6. Number of Participants Meeting DSM-IV Cocaine Dependence Criteria [12-months post-baseline]

   Number of participants meeting DSM-IV cocaine dependence criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• opiate dependence

• newly admitted to methadone treatment

Exclusion Criteria:

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institutes for Behavior Resources REACH	Baltimore	Maryland	United States	21218
2	University of Maryland Drug Treatment Center	Baltimore	Maryland	United States	21223

Sponsors and Collaborators

• Friends Research Institute, Inc.

Investigators

• Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01442493
• Other Study ID Numbers: 2R01DA015842
• First Posted: Sep 28, 2011
• Last Update Posted: Dec 29, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Friends Research Institute, Inc.: Methadone Treatment; Opiate dependence; Services research
• Additional relevant MeSH terms: Opioid-Related Disorders; Methadone

Study Results

Participant Flow

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	149	151
COMPLETED	146	149
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	146	149	295
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (10.3)	42.0 (9.8)	42.7 (10.1)
Sex: Female, Male (Count of Participants)
Female	54 37%	67 45%	121 41%
Male	92 63%	82 55%	174 59%
Race/Ethnicity, Customized (Count of Participants)
Black	90 61.6%	81 54.4%	171 58%
White	56 38.4%	66 44.3%	122 41.4%
Hispanic	0 0%	2 1.3%	2 0.7%
Region of Enrollment (participants) [Number]
United States	146 100%	149 100%	295 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Opiate Positive Urine Tests
Description	Number of participants with opiate positive urine tests
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

Missing data were counted as positive

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Count of Participants [Participants]	89 61%	90 60.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Number of Participants With Cocaine Positive Urine Tests
Description	Cocaine positive urine drug test
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

Missing data were considered positive

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Count of Participants [Participants]	67 45.9%	85 57%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Drug Use HIV Risk Behavior
Description	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

Outcome Measure Data

Analysis Population Description

Baseline values were used when 12 month data were missing.

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Mean (Standard Deviation) [units on a scale]	0.72 (2.56)	1.36 (3.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Criminal Behavior
Description	Days of criminal behavior
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Mean (Standard Deviation) [Number of Days in the Past 30 days]	2.99 (.75)	3.72 (.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Global Score on the World Health Organization Quality of Life Measure
Description	Scale from 1 through 5. A higher score reflects a better quality of life.
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

Baseline values were used when 12 month data were missing

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Mean (Standard Deviation) [units on a scale]	3.70 (0.91)	3.47 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Description	Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

Baseline values were used when 12 month data were missing

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Count of Participants [Participants]	88 60.3%	103 69.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Description	Number of participants meeting DSM-IV cocaine dependence criteria
Time Frame	12-months post-baseline

Outcome Measure Data

Analysis Population Description

Baseline values were used when 12 month data were missing

Arm/Group Title	Patient-Centered Methadone Treatment	Methadone Treatment as Usual
Arm/Group Description	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 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.
Measure Participants	146	149
Count of Participants [Participants]	41 28.1%	52 34.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Methadone Treatment, Methadone Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	All Serious Adverse Events were considered unrelated to study participation.
Arm/Group Title	Patient-Centered Methadone Treatment		Methadone Treatment as Usual
Arm/Group Description	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 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.
All Cause Mortality
	Patient-Centered Methadone Treatment		Methadone Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/146 (1.4%)		4/149 (2.7%)
Serious Adverse Events
	Patient-Centered Methadone Treatment		Methadone Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/146 (21.2%)		36/149 (24.2%)
Cardiac disorders
Myocardial infarction	2/146 (1.4%)		0/149 (0%)
Chest Pain	3/146 (2.1%)		1/149 (0.7%)
Angina	1/146 (0.7%)		0/149 (0%)
Congestive Heart Failure	0/146 (0%)		1/149 (0.7%)
Endocrine disorders
Pancreatitis	1/146 (0.7%)		0/149 (0%)
Diabetes Mellitus	1/146 (0.7%)		1/149 (0.7%)
Gastrointestinal disorders
Vomiting	2/146 (1.4%)		1/149 (0.7%)
Ulcer	0/146 (0%)		1/149 (0.7%)
Food poisoning	0/146 (0%)		1/149 (0.7%)
General disorders
Dehydration	0/146 (0%)		1/149 (0.7%)
Immune system disorders
Lupus	0/146 (0%)		1/149 (0.7%)
Infections and infestations
Soft Tissue Infection	6/146 (4.1%)		4/149 (2.7%)
HIV	1/146 (0.7%)		0/149 (0%)
Injury, poisoning and procedural complications
Trauma	3/146 (2.1%)		2/149 (1.3%)
Overdose	2/146 (1.4%)		3/149 (2%)
Infected catheter	0/146 (0%)		1/149 (0.7%)
Poisoning of Unknown Origin and Type	0/146 (0%)		1/149 (0.7%)
Metabolism and nutrition disorders
Gout	1/146 (0.7%)		0/149 (0%)
Musculoskeletal and connective tissue disorders
Pain in Back, Hip, Jaw, Groin	3/146 (2.1%)		0/149 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer	0/146 (0%)		1/149 (0.7%)
Nervous system disorders
Seizures	2/146 (1.4%)		2/149 (1.3%)
Altered Mental Status	1/146 (0.7%)		0/149 (0%)
Psychiatric disorders
Depression	2/146 (1.4%)		4/149 (2.7%)
Suicide attempt	0/146 (0%)		2/149 (1.3%)
Psychiatric Disorder Unspecified	0/146 (0%)		3/149 (2%)
Renal and urinary disorders
Renal Failure	0/146 (0%)		1/149 (0.7%)
Kidney stone	0/146 (0%)		1/149 (0.7%)
Kidney Infection	0/146 (0%)		1/149 (0.7%)
Reproductive system and breast disorders
Fibroids	1/146 (0.7%)		0/149 (0%)
Spontaneous abortion	1/146 (0.7%)		1/149 (0.7%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	5/146 (3.4%)		3/149 (2%)
Bronchitis	2/146 (1.4%)		0/149 (0%)
Asthma	1/146 (0.7%)		2/149 (1.3%)
Chronic Obstructive Pulmonary Disease	1/146 (0.7%)		0/149 (0%)
Dyspnea	1/146 (0.7%)		0/149 (0%)
Pulmonary Edema	0/146 (0%)		1/149 (0.7%)
Surgical and medical procedures
Knee Surgery	1/146 (0.7%)		0/149 (0%)
Tonsillectomy	1/146 (0.7%)		0/149 (0%)
Vascular disorders
Hypertension	4/146 (2.7%)		1/149 (0.7%)
Stroke	2/146 (1.4%)		1/149 (0.7%)
Pulmonary Embolism	1/146 (0.7%)		2/149 (1.3%)
Thrombosis	0/146 (0%)		2/149 (1.3%)
Varices	0/146 (0%)		1/149 (0.7%)
Edema	0/146 (0%)		1/149 (0.7%)
Other (Not Including Serious) Adverse Events
	Patient-Centered Methadone Treatment		Methadone Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/146 (0%)		0/149 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.