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Delivering Contingency Management in Outpatient Addiction Treatment (PRISE)

Primary Purpose

Methamphetamine, Methamphetamine Abuse, Methamphetamine-dependence

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Contingency management
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methamphetamine focused on measuring Contingency Management, Methamphetamine, Substance Use, Treatment, Internet-Based Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-years of age or older
  • Seeking treatment for methamphetamine use or substance use issues other than methamphetamine use
  • Reported methamphetamine use or substance use other than methamphetamine use within 3-months prior to study entry
  • Deemed appropriate for treatment-as-usual using Alberta Health Services clinical procedures
  • Willing to participate in the 12-week intervention in-person or virtually at least once weekly
  • Willing to participate in-person or virtually for a follow-up at 3, 6, and 12-months following the 12-week intervention period
  • Willing to complete questionnaires weekly during the 12-week intervention period and at each follow-up at 3, 6, and 12-months following the 12-week intervention period

Exclusion Criteria:

  • Past or current history of gambling problems
  • Imminent plans to enter an environment in which participation in this study is restricted (e.g., residential treatment, inpatient unit, detoxification, incarceration, house arrest).

Sites / Locations

  • Adult Addiction Services in Alberta Health Services
  • Addiction Services Edmonton in Alberta Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Contingency management for treatment attendance

Treatment-as-usual

Arm Description

Participants who receive contingency management in addition to their usual care (treatment-as-usual). These participants are in the 12-week contingency management program which provides incentives for their treatment attendance.

Participants who solely receive their usual care (treatment-as-usual) and do not receive contingency management.

Outcomes

Primary Outcome Measures

Differences in Treatment Retention from Baseline to Post-Intervention at Week 12
The number of days between the first and last scheduled treatment session.

Secondary Outcome Measures

Proportion of Methamphetamine Abstinent Days Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Longest Consecutive Days of Methamphetamine Abstinence Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Longest Consecutive Days of Methamphetamine Use Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Proportion of Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Longest Consecutive Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Longest Consecutive Days of Use of Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Mean Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Total Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Largest Number of Units Consumed of Other Quantifiable Licit and Illicit Substances in One Day Measured Using the Timeline Followback (TLFB) Questionnaire
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Proportion of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Longest Consecutive Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Longest Consecutive Days Absent from Scheduled Treatment from Baseline to Post-Intervention at Week 12
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Mean Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Total Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).

Full Information

First Posted
September 2, 2020
Last Updated
May 8, 2023
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT04544124
Brief Title
Delivering Contingency Management in Outpatient Addiction Treatment
Acronym
PRISE
Official Title
Expanding Capacity in Alberta to Deliver Contingency Patient Management in Outpatient Addiction Treatment: A Randomized Clinical Trial for Methamphetamine Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Methamphetamine misuse has become a growing concern in Alberta, creating a burden on the health care system. Further, individuals who use methamphetamine in Alberta exhibit significant difficulty remaining in treatment. These troubling patterns necessitate the provision of evidence-based practices (EBPs)-those grounded in empirical evidence-to ensure the best possible care and outcomes for those struggling with this addiction. Within the field of substance use (SU), contingency management (CM) is an extensively studied evidence-based treatment (EBT) for addictive disorders. CM is an intervention that provides incentives to encourage positive behavioural change. Compared to standard care (treatment-as-usual (TAU)), CM has resulted in improvements in abstinence, attendance, adherence, retention, and quality of life. The efficacy of CM has largely been investigated in the context of reinforcing abstinence, though the literature suggests that CM which reinforces attendance may be as effective. Research from the US has examined the cost-effectiveness of CM and found that although CM costs more, it was associated with greater abstinence, treatment completion, and substance-absent urine compared to TAU. Despite the promising literature, the uptake of CM in Canada is limited making it difficult to understand whether this EBT is equally efficacious as compared to the US. This study will implement and evaluate the efficacy of virtually delivered attendance-based CM in outpatient addiction treatment in Alberta. Participants (N=544) will be individuals seeking treatment for methamphetamine use (n=304) and individuals seeking treatment for substance use issues other than methamphetamine use (n=240). It is hypothesized that compared to participants in TAU, participants in CM will evidence: (1) greater retention, (2) greater attendance, (3) greater abstinence from methamphetamine and less methamphetamine use, (4) greater abstinence from other SU and less SU, and (5) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based remote versus in-person delivery of CM; outcomes differ between participants who use methamphetamine and participants who use substances other than methamphetamine; the costs of CM differ from TAU; CM changes health service use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine, Methamphetamine Abuse, Methamphetamine-dependence, Contingency Management, Substance Use, Substance Abuse, Substance Use Disorders, Drug Use, Drug Abuse, Adults, Humans
Keywords
Contingency Management, Methamphetamine, Substance Use, Treatment, Internet-Based Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants who use methamphetamine and participants who use substances other than methamphetamine will randomly be assigned to one of two treatment arms: contingency management which incentivizes participants for their treatment attendance or treatment-as-usual with no contingency management.
Masking
None (Open Label)
Masking Description
Given incentivization will occur for attendance, it is not possible to blind conditions.
Allocation
Randomized
Enrollment
544 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingency management for treatment attendance
Arm Type
Experimental
Arm Description
Participants who receive contingency management in addition to their usual care (treatment-as-usual). These participants are in the 12-week contingency management program which provides incentives for their treatment attendance.
Arm Title
Treatment-as-usual
Arm Type
No Intervention
Arm Description
Participants who solely receive their usual care (treatment-as-usual) and do not receive contingency management.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Intervention Description
Incentives will be provided for treatment attendance over a 12-week period.
Primary Outcome Measure Information:
Title
Differences in Treatment Retention from Baseline to Post-Intervention at Week 12
Description
The number of days between the first and last scheduled treatment session.
Time Frame
Baseline to Post-Intervention at Week 12.
Secondary Outcome Measure Information:
Title
Proportion of Methamphetamine Abstinent Days Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Longest Consecutive Days of Methamphetamine Abstinence Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Longest Consecutive Days of Methamphetamine Use Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of methamphetamine will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Proportion of Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Longest Consecutive Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Longest Consecutive Days of Use of Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Mean Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Total Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Largest Number of Units Consumed of Other Quantifiable Licit and Illicit Substances in One Day Measured Using the Timeline Followback (TLFB) Questionnaire
Description
The TLFB is an instrument that assesses retrospective substance use. Abstinence from and use of other licit and illicit substances will be examined using the TLFB based on Robinson and colleagues' definitions (2014) over the intervention period and follow-up periods.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Proportion of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Description
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Time Frame
Baseline to Post-Intervention at Week 12.
Title
Longest Consecutive Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Description
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Time Frame
Baseline to Post-Intervention at Week 12.
Title
Longest Consecutive Days Absent from Scheduled Treatment from Baseline to Post-Intervention at Week 12
Description
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Time Frame
Baseline to Post-Intervention at Week 12.
Title
Mean Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Description
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Time Frame
Baseline to Post-Intervention at Week 12.
Title
Total Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12
Description
Attendance will be defined based on definitions in Petry and colleagues' (2018) and Robinson and colleagues' (2014).
Time Frame
Baseline to Post-Intervention at Week 12.
Other Pre-specified Outcome Measures:
Title
Changes in Quality of Life Measured Using the 26-item World Health Organization (WHO) Quality of Life-BREF (WHOQOL-BREF)
Description
The WHOQOL-BREF is a 26-item self-report instrument that measures quality of life across four domains: physical health, psychological health, social relationships, and environment.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Differences in Outcome Measures Between Remote and In-Person Delivery of Contingency Management
Description
To explore whether the pre-specified outcomes differ between participants who choose to attend their contingency management remotely and participants who choose to attend their contingency management in-person.
Time Frame
Baseline to Post-Intervention Week 12.
Title
Differences in Outcomes Between Participants Seeking Treatment for Methamphetamine Use and Participants Seeking Treatment for Substance Use Issues Other Than Methamphetamine Use
Description
To explore whether the pre-specified outcomes differ between participants who are seeking treatment for methamphetamine use and participants seeking treatment for substance use issues other than methamphetamine use.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).
Title
Differences in Costs Between Contingency Management and Treatment-As-Usual
Description
To explore differences in the costs of providing contingency management for treatment attendance and treatment-as-usual alone.
Time Frame
Baseline to Post-Intervention Week 12.
Title
Differences in Health Service Use Between Contingency Management and Treatment-As-Usual
Description
To explore differences in health service use between the experimental group which examines contingency management for treatment attendance and the treatment-as-usual alone group as measured by the number of (a) emergency department visits, (b) visits to urgent care centers, (c) hospitalizations, and (d) enrolments in other treatment services.
Time Frame
Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-years of age or older Seeking treatment for methamphetamine use or substance use issues other than methamphetamine use Reported methamphetamine use or substance use other than methamphetamine use within 3-months prior to study entry Deemed appropriate for treatment-as-usual using Alberta Health Services clinical procedures Willing to participate in the 12-week intervention in-person or virtually at least once weekly Willing to participate in-person or virtually for a follow-up at 3, 6, and 12-months following the 12-week intervention period Willing to complete questionnaires weekly during the 12-week intervention period and at each follow-up at 3, 6, and 12-months following the 12-week intervention period Exclusion Criteria: Past or current history of gambling problems Imminent plans to enter an environment in which participation in this study is restricted (e.g., residential treatment, inpatient unit, detoxification, incarceration, house arrest). Attended more than one treatment session since their intake, or screening date was more than one month following their first day of treatment at the Alberta Health Services clinic No plans to attend weekly treatment at the Alberta Health Services clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Hodgins, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adult Addiction Services in Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0B3
Country
Canada
Facility Name
Addiction Services Edmonton in Alberta Health Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 0G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Impacts of Methamphetamine Abuse in Canada: Hearing Before the House of Comm. Standing Committee on Health, 126 Report, 42nd Parliament, 1st Sess. (Nov. 29, 2018).
Results Reference
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Citation
Dozois DJA, Mikail SF, Alden LE, Bieling PJ, Bourgon G, Clark DA, et al. The CPA presidential task force on evidence-based practice of psychological treatments. Canadian Psychology/Psychologie Canadienne. 2014;55(3):153-160.
Results Reference
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PubMed Identifier
8555924
Citation
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996 Jan 13;312(7023):71-2. doi: 10.1136/bmj.312.7023.71. No abstract available.
Results Reference
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Citation
Petry NM. Contingency management for substance abuse treatment: a guide for implementing this evidence-based practice. New York: Taylor & Francis Group; 2012.
Results Reference
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PubMed Identifier
16203960
Citation
Petry NM, Peirce JM, Stitzer ML, Blaine J, Roll JM, Cohen A, Obert J, Killeen T, Saladin ME, Cowell M, Kirby KC, Sterling R, Royer-Malvestuto C, Hamilton J, Booth RE, Macdonald M, Liebert M, Rader L, Burns R, DiMaria J, Copersino M, Stabile PQ, Kolodner K, Li R. Effect of prize-based incentives on outcomes in stimulant abusers in outpatient psychosocial treatment programs: a national drug abuse treatment clinical trials network study. Arch Gen Psychiatry. 2005 Oct;62(10):1148-56. doi: 10.1001/archpsyc.62.10.1148.
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Citation
Petry NM, Alessi SM, Rash CJ, Barry D, Carroll KM. A randomized trial of contingency management reinforcing attendance at treatment: Do duration and timing of reinforcement matter? J Consult Clin Psychol. 2018 Oct;86(10):799-809. doi: 10.1037/ccp0000330.
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Citation
Higgins ST, Budney AJ, Bickel WK, Foerg FE, Donham R, Badger GJ. Incentives improve outcome in outpatient behavioral treatment of cocaine dependence. Arch Gen Psychiatry. 1994 Jul;51(7):568-76. doi: 10.1001/archpsyc.1994.03950070060011.
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Citation
Roll JM, Chudzynski J, Cameron JM, Howell DN, McPherson S. Duration effects in contingency management treatment of methamphetamine disorders. Addict Behav. 2013 Sep;38(9):2455-62. doi: 10.1016/j.addbeh.2013.03.018. Epub 2013 Apr 3.
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Andrade LF, Alessi SM, Petry NM. The impact of contingency management on quality of life among cocaine abusers with and without alcohol dependence. Am J Addict. 2012 Jan-Feb;21(1):47-54. doi: 10.1111/j.1521-0391.2011.00185.x. Epub 2011 Nov 18.
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Citation
Sindelar J, Elbel B, Petry NM. What do we get for our money? Cost-effectiveness of adding contingency management. Addiction. 2007 Feb;102(2):309-16. doi: 10.1111/j.1360-0443.2006.01689.x.
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Delivering Contingency Management in Outpatient Addiction Treatment

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