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Opiate-Replacement TherapyEarly Phase 1NCT01229163

Automated Prize-based Contingency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients

A Early Phase 1 study testing Automated Contingency Management (ACM) software in people with Opiate-Replacement Therapy, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

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

Background: Treatment outcomes for substance abuse are improved by regular attendance at counseling sessions, and attending at counseling sessions can be futher improved by prize-based incentives. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Opiate-Replacement Therapy
What is being tested?
Automated Contingency Management (ACM) software
Type of treatment
Medical device
How many people
25 participants
Where
1 siteUnited States
Study dates
3 Oct 2010to 19 Apr 2012
Phase
Early Phase 1
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Enrollment in a substance abuse treatment protocol in Archway, with attendance having started at least 4 weeks prior to admission into this protocol (to allow time for stabilization in treatment).

Who cannot join

  • Less than 14 weeks remaining in primary protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institute on Drug Abuse, Biomedical Research Center (BRC)

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Automated Prize-Based Contigency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients

Background:

  • Treatment outcomes for substance abuse are improved by regular attendance at counseling sessions, and attending at counseling sessions can be futher improved by prize-based incentives. However, a system of prize-based incentives can be difficult to administer without computerization for accurate recordkeeping and rapid calculation of earnings. NIDA researchers have developed the eXtensible Platform for Motivational Incentives (XPMI), a computer program that for reinforcement of weekly counseling attendance. Users are eligible to win prizes through automated draws. The researchers are interested in testing the effectiveness and ease of use of the XPMI software so it can ultimately be run by staff in community treatment programs.
Read more

Objectives:

  • To test the XPMI program in a clinic setting, with emphasis on its functionality, usability, and acceptability for counselors.
  • To test and validate XPMI s accuracy in calculating incentives to reinforce drug abstinence.

Eligibility:

  • Individuals at least 18 years of age who are participating in clinical trials for treatment of heroin dependence in an outpatient treatment-research program, and have at least 14 weeks remaining in the program.

Design:

  • Participants will meet with their counselors as regularly scheduled. Twelve of the visits will count toward this study, with 2 extra weeks in case of counselor absence or clinic closure.
  • Participants will receive an incentive in the form of a prize draw for arriving to counseling appointments on time, on the scheduled day. (Participants may reschedule one appointment per week without losing the chance for a prize draw.) For each consecutive appointment attended on time, participants will receive extra prize draws; attending three counseling appointments in a row can earn four bonus prize draws.
  • To draw for prizes, participants will push a button on a computer. Each prize draw could result in a small prize worth $1 to $2, a large prize worth $20, a jumbo prize worth $100, or no prize at all. The average prize total per person is expected to be about $378.
  • Participants will also be asked to fill out questionnaires about the computer program.
Read the detailed description

Background. Community implementation is a barrier to technology transfer of contingency management (CM), an effective behavioral treatment for substance dependence. The Biomedical Informatics Section (BIS), the Treatment Section, and the NIDA Blending team are developing and validating software for automated contingency management (ACM) for free distribution and use in community treatment programs. This is part of a collaborative effort between NIDA and SAMHSA to facilitate use of CM in the community.

Scientific goals. To validate the usability and robustness of our ACM program, eXtensible Platform for Motivational Incentives (XPMI), implemented under conditions simulating those of a community treatment program with minimal technology support.

Participant population. Up to 30 outpatients (20 completers) participating in treatment studies at Archway clinic. Target enrollment for the outpatients will include 30% women and 60% minorities (mostly African-American).

Experimental design and methods. In this field test, Archway counseling staff will use XPMI to reinforce participants attendance at up to 12 counseling sessions for up to 14 weeks. (Participants who are still enrolled in the clinic at the end of this period will be considered completers.) Participants will earn opportunities to draw for prizes each time they attend their weekly counseling session on time and as scheduled. A record of any problems in using the program and the possible recommended solutions will be maintained. Feedback on problems, accuracy, and simplicity will be given to the software-development team at BIS on an ongoing basis. BIS will fix any problems as they arise.

Benefits to participants and/or society. There are no direct benefits to the participants. Availability of XPMI may improve technology transfer of a proven effective treatment to the community.

Risks to participants. Risks of participation are minimal. This is a secondary study; participants decisions about enrollment and compliance will not affect their status in their primary studies.

Being tested
Automated Contingency Management (ACM) software
Keywords
Motivational Incentive, Automation, Contingency Management, Counseling Adherance

What participants receive

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

  • Automated Contingency Management (ACM) softwareDevice

What is being measured

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

  1. Participant Feedback; Counselor Feedback; XPMI Performance

Timeline

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

  1. First posted27 Oct 2010 (estimated)
  2. Study start3 Oct 2010
  3. Primary completion9 Apr 2012
  4. Study completion19 Apr 2012

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
Early Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01229163
Sponsor's protocol ID
999911464
Other IDs
11-DA-N464
Status last verified
31 May 2013
First submitted
26 Oct 2010
Last updated
5 Apr 2018
Results posted
No

Publications

  • Ghitza UE, Epstein DH, Schmittner J, Vahabzadeh M, Lin JL, Preston KL. Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin. J Consult Clin Psychol. 2007 Oct;75(5):765-74. doi: 10.1037/0022-006X.75.5.765.

    PubMed 17907858

  • Ghitza UE, Epstein DH, Schmittner J, Vahabzadeh M, Lin JL, Preston KL. Effect of reinforcement probability and prize size on cocaine and heroin abstinence in prize-based contingency management. J Appl Behav Anal. 2008 Winter;41(4):539-49. doi: 10.1901/jaba.2008.41-539.

    PubMed 19192858

  • Lin JL, Vahabzadeh M, Mezghanni M, Epstein DH, Preston KL. A high-level specification for adaptive ecological momentary assessment: real-time assessment of drug craving, use and abstinence. AMIA Annu Symp Proc. 2005;2005:455-9.

    PubMed 16779081

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Automated Contingency Management (ACM) software in people with Opiate-Replacement Therapy, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

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 1 inclusion and 1 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Participant Feedback; Counselor Feedback; XPMI Performance. 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 NCT01229163, which also lists 3 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 5 Apr 2018.

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