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MethamphetaminePRISENCT04544124

Delivering Contingency Management in Outpatient Addiction Treatment

A study testing Contingency management in people with Methamphetamine and Methamphetamine Abuse, run by University of Calgary at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Contingency management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesCanada
Study dates
25 Jan 2021to 8 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Adult Addiction Services in Alberta Health Services

    Calgary, Alberta, T2R 0B3

  • Addiction Services Edmonton in Alberta Health Services

    Edmonton, Alberta, T5J 0G5

Other trials in Canada

About this study

Official title: Expanding Capacity in Alberta to Deliver Contingency Patient Management in Outpatient Addiction Treatment: A Randomized Clinical Trial for Methamphetamine Use

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.

Being tested
Contingency management
Keywords
Contingency Management, Methamphetamine, Substance Use, Treatment, Internet-Based Intervention
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency managementBehavioural

    Incentives will be provided for treatment attendance over a 12-week period.

Study groups in NCT04544124
Study groupRoleWhat they receive
Contingency management for treatment attendanceExperimentalParticipants 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.
Receives: Behavioral: Contingency management
Treatment-as-usualNo interventionParticipants who solely receive their usual care (treatment-as-usual) and do not receive contingency management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in Treatment Retention from Baseline to Post-Intervention at Week 12

    The number of days between the first and last scheduled treatment session.

    Measured: Baseline to Post-Intervention at Week 12.

Secondary outcomes (14)
  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. 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.

    Measured: 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).

  4. 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.

    Measured: 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).

  5. 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.

    Measured: 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).

  6. 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.

    Measured: 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).

  7. 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.

    Measured: 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).

  8. 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.

    Measured: 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).

  9. 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.

    Measured: 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. 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).

    Measured: Baseline to Post-Intervention at Week 12.

  11. 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).

    Measured: Baseline to Post-Intervention at Week 12.

  12. 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).

    Measured: Baseline to Post-Intervention at Week 12.

  13. 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).

    Measured: Baseline to Post-Intervention at Week 12.

  14. 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).

    Measured: Baseline to Post-Intervention at Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start25 Jan 2021
  3. Primary completion22 Dec 2022
  4. Study completion8 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544124
Sponsor's protocol ID
200443
Other IDs
2021-HQ-000013
Acronym
PRISE
Status last verified
Feb 2024
First submitted
2 Sep 2020
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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).

  • 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.

  • 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.

    PubMed 8555924
  • Petry NM. Contingency management for substance abuse treatment: a guide for implementing this evidence-based practice. New York: Taylor & Francis Group; 2012.

  • 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.

    PubMed 16203960
  • 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.

    PubMed 30265039
  • 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.

    PubMed 8031230
  • 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.

    PubMed 23708468
  • 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.

    PubMed 22211346
  • 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.

    PubMed 17222286
  • CRISM-Alberta Health Services. Demographics and service utilization patterns of clients enrolled in specialty addiction treatment for amphetamine use, 2012-2018; Edmonton (Alberta): Canadian Research Initiative in Substance Misuse (CRISM); 2019 Jun. 22 p.

  • Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31.

    PubMed 23276315
  • Sobell LC, Sobell MB. Timeline follow-back: a technique for assessing self-reported alcohol consumption. In Litten RZ, Allen JP (eds). Measuring Alcohol Consumption. Totowa, NJ: Humana Press; 1992:41-72. doi: 10.1007/978-1-4612-0357-5_3

  • Agrawal S, Sobell MB, Sobell LC. The timeline followback: a scientifically and clinically useful tool for assessing substance use. In Belli RB, Stafford FP, Alwin DF (eds). Calendar and Time Diary. Sage Publications Inc; 2009:57-68. doi: 10.4135/9781412990295.d8

Questions about this trial

What is this clinical trial studying?

A study testing Contingency management in people with Methamphetamine and Methamphetamine Abuse, run by University of Calgary at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Treatment Retention from Baseline to Post-Intervention at Week 12 (time frame: Baseline to Post-Intervention at Week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04544124, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.

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