Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management | Experimental | Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value. |
|
| Placebo | Placebo Comparator | Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric Status | Kessler Psychological Distress Scale (K10) - score range 10 to 50.
| 8 weeks, 6 months, 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hildi J. Hagedorn, PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States | ||
| VA Puget Sound Health Care System Seattle Division, Seattle, WA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23453480 | Result | 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 Feb 28. | |
| 25008457 | Result | 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 centers. Addict Sci Clin Pract. 2014 Jul 9;9(1):12. doi: 10.1186/1940-0640-9-12. |
Not provided
Not provided
Two participants withdrew from participation after random assignment to the placebo condition and did not start the intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Contingency Management | 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. |
| FG001 | Placebo | Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention |
| |||||||||||||
| Six Month Follow up |
| |||||||||||||
| 12 Month Follow up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Contingency Management | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 | Posted | Mean | Standard Deviation | negative alcohol and drug screens | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contingency Management | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hildi Hagedorn | Minneapolis VA Health Care System | 612-467-3875 | hildi.hagedorn@va.gov |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. |
|
| 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. |
| Housing | Number of participants reporting stable housing (owned or rented house, apartment or room) | 8 week, 6 month and 12 month follow-ups |
| Legal Status | Number of participants reporting detention or incarceration in the previous 30 days | 8 weeks, 6 month and 12 month follow ups |
| Employment Status | Number of participants identifying themselves as unemployed. | 8 week, 6 month and 12 month follow up |
| Seattle |
| Washington |
| 98108 |
| United States |
| 28673526 | Result | 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;79:46-52. doi: 10.1016/j.jsat.2017.05.013. Epub 2017 May 25. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Placebo |
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Psychiatric Status | Kessler Psychological Distress Scale (K10) - score range 10 to 50.
| Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week assessment. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | Dollars | 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) | Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week follow up assessment. | Posted | Count of Participants | Participants | 8 week, 6 month and 12 month follow-ups |
|
|
|
|
| Secondary | Legal Status | Number of participants reporting detention or incarceration in the previous 30 days | Lower numbers of participants returned for 6 and 12 month follow up assessments compared to 8 week follow up assessment. | Posted | Count of Participants | Participants | 8 weeks, 6 month and 12 month follow ups |
|
|
|
|
| Secondary | Employment Status | Number of participants identifying themselves as unemployed. | Fewer participants completed 6 and 12 month follow up assessments compared to 8 week follow up assessment. | Posted | Count of Participants | Participants | 8 week, 6 month and 12 month follow up |
|
|
|
|
| 49 |
| 165 |
| 0 |
| 165 |
| EG001 | Baseline | Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. | 53 | 165 | 0 | 165 |
| Hospitalization | General disorders |
|
| Hospitalization | Psychiatric disorders |
|
Not provided
Not provided
Not provided
| 6 month outcomes |
|
|
| 12 month outcomes |
|
|
| 0.45 |
a priori threshold of <.05 |
| Superiority |
| 12 month analysis | t-test, 2 sided | .0497 | a prior threshold of .05 | Superiority |
| Estimating Equation mean modeling |
| >.05 |
| Superiority |
| Housing status at 6 months |
|
|
| Housing at 12 months |
|
|
| .013 |
A priori threshold <.05 |
| Superiority |
| Analysis for 12 month follow up | Chi-squared | .76 | A priori threshold <.05 | Superiority |
| Legal status at 6 month follow-up |
|
|
| Legal status at 12 month follow up |
|
|
| .37 |
A priori threshold <.05 |
| Superiority |
| Analysis for 12 month follow up. | Chi-squared | .19 | a priori threshold <.05 | Superiority |
| Employment status at 6 month follow-up |
|
|
| Employment status at 12 week follow-up |
|
|
| .80 |
A priori threshold of <.05 |
| Superiority |
| Analysis for 12 month follow-up. | Chi-squared | .12 | A priori threshold of <.05 | Superiority |