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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252512
Other study ID # IIR 03-120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date February 2010

Study information

Verified date July 2018
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.


Description:

Design: This will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the Minneapolis VAMC and the VA Puget Sound Health Care System will be randomly assigned to 8 weeks of Usual Care or Usual Care plus Contingency Management. Minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. Randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). All participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. Participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. The number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. Half of the 500 tokens will result in social reinforcement ("Good Job!"). The remainder will earn a VA canteen voucher worth monetary value. Follow-up assessments occur 2, 6, and 12 months after enrollment into the study. Primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the Timeline Follow-Back interview at follow-up assessments. Secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on VA service utilization. A process evaluation and an economic analysis are included.


Recruitment information / eligibility

Status Completed
Enrollment 332
Est. completion date February 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence

Exclusion Criteria:

- primary cannabis dependence

- primary opioid dependence

- severe psychiatric symptoms

- suicide risk

- positive history or screen for pathological gambling

- lacking transportation or living too far away to attend twice per week research appointments

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Contingency Management
Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
Other:
Placebo
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.

Locations

Country Name City State
United States Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hagedorn HJ, Noorbaloochi S, Bangerter A, Stitzer ML, Kivlahan D. Health care cost trajectories in the year prior to and following intake into Veterans Health Administration outpatient substance use disorders treatment. J Subst Abuse Treat. 2017 Aug;79:46 — View Citation

Hagedorn HJ, Noorbaloochi S, Simon AB, Bangerter A, Stitzer ML, Stetler CB, Kivlahan D. Rewarding early abstinence in Veterans Health Administration addiction clinics. J Subst Abuse Treat. 2013 Jul;45(1):109-17. doi: 10.1016/j.jsat.2013.01.006. Epub 2013 — View Citation

Hagedorn HJ, Stetler CB, Bangerter A, Noorbaloochi S, Stitzer ML, Kivlahan D. An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical ce — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 8 weeks
Secondary Psychiatric Status Kessler Psychological Distress Scale (K10) - score range 10 to 50.
score under 20 are likely to be well
score 20-24 are likely to have mild psychological distress
score 25-29 are likely to have moderate psychological distress
score 30 and over are likely to have a severe psychological distress
8 weeks, 6 months, 12 months
Secondary VHA Healthcare Service Utilization Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up. Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
Secondary Housing Number of participants reporting stable housing (owned or rented house, apartment or room) 8 week, 6 month and 12 month follow-ups
Secondary Legal Status Number of participants reporting detention or incarceration in the previous 30 days 8 weeks, 6 month and 12 month follow ups
Secondary Employment Status Number of participants identifying themselves as unemployed. 8 week, 6 month and 12 month follow up
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