Substance Use Disorders
Conditions
Keywords
Contingency management interventions, Substance use disorders treatment, Treatment effectiveness, Randomized clinical trial, Behavioral research
Brief 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.
Detailed 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.
Interventions
BEHAVIORALContingency 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.
OTHERPlacebo
Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric Status | 8 weeks, 6 months, 12 months | 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 |
| VHA Healthcare Service Utilization | Baseline to 6 month follow up and 6 month follow up to 12 month follow up. | 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. |
| Housing | 8 week, 6 month and 12 month follow-ups | Number of participants reporting stable housing (owned or rented house, apartment or room) |
| Legal Status | 8 weeks, 6 month and 12 month follow ups | Number of participants reporting detention or incarceration in the previous 30 days |
| Employment Status | 8 week, 6 month and 12 month follow up | Number of participants identifying themselves as unemployed. |
Countries
United States
Participant flow
Pre-assignment details
Two participants withdrew from participation after random assignment to the placebo condition and did not start the intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 165 |
| Placebo Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results. | 165 |
| Total | 330 |
Baseline characteristics
| Characteristic | Contingency Management | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 9.7 | 49.3 years STANDARD_DEVIATION 8.9 | 49.5 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 162 Participants | 320 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 113 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 29 Participants | 14 Participants |
| Race (NIH/OMB) White | 90 Participants | 188 Participants | 98 Participants |
| Region of Enrollment United States | 165 Participants | 330 Participants | 165 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 160 Participants | 323 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 165 | 0 / 165 |
| serious Total, serious adverse events | 49 / 165 | 53 / 165 |
Outcome results
Primary
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management | Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 | 11.93 negative alcohol and drug screens | Standard Deviation 4.67 |
| Placebo | Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16 | 10.39 negative alcohol and drug screens | Standard Deviation 5.18 |
p-value: <0.001GEE full factorial modeling
Secondary
Employment Status
Number of participants identifying themselves as unemployed.
Time frame: 8 week, 6 month and 12 month follow up
Population: Fewer participants completed 6 and 12 month follow up assessments compared to 8 week follow up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contingency Management | Employment Status | Employment status at 8 week follow-up | 74 Participants |
| Contingency Management | Employment Status | Employment status at 6 month follow-up | 51 Participants |
| Contingency Management | Employment Status | Employment status at 12 week follow-up | 32 Participants |
| Placebo | Employment Status | Employment status at 8 week follow-up | 57 Participants |
| Placebo | Employment Status | Employment status at 6 month follow-up | 49 Participants |
| Placebo | Employment Status | Employment status at 12 week follow-up | 43 Participants |
Comparison: Analysis for 8 week follow-upp-value: 0.05Chi-squared
Comparison: Analysis for 6 month follow-up.p-value: 0.8Chi-squared
Comparison: Analysis for 12 month follow-up.p-value: 0.12Chi-squared
Secondary
Housing
Number of participants reporting stable housing (owned or rented house, apartment or room)
Time frame: 8 week, 6 month and 12 month follow-ups
Population: Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week follow up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contingency Management | Housing | Housing status at 8 weeks | 77 Participants |
| Contingency Management | Housing | Housing status at 6 months | 80 Participants |
| Contingency Management | Housing | Housing at 12 months | 88 Participants |
| Placebo | Housing | Housing status at 8 weeks | 66 Participants |
| Placebo | Housing | Housing status at 6 months | 91 Participants |
| Placebo | Housing | Housing at 12 months | 88 Participants |
Comparison: Analysis for 8 week follow upp-value: 0.28Chi-squared
Comparison: Analysis for 6 month follow upp-value: 0.013Chi-squared
Comparison: Analysis for 12 month follow upp-value: 0.76Chi-squared
Secondary
Legal Status
Number of participants reporting detention or incarceration in the previous 30 days
Time frame: 8 weeks, 6 month and 12 month follow ups
Population: Lower numbers of participants returned for 6 and 12 month follow up assessments compared to 8 week follow up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contingency Management | Legal Status | Legal status at 8 week follow-up | 3 Participants |
| Contingency Management | Legal Status | Legal status at 6 month follow-up | 6 Participants |
| Contingency Management | Legal Status | Legal status at 12 month follow up | 3 Participants |
| Placebo | Legal Status | Legal status at 12 month follow up | 7 Participants |
| Placebo | Legal Status | Legal status at 8 week follow-up | 2 Participants |
| Placebo | Legal Status | Legal status at 6 month follow-up | 3 Participants |
Comparison: Analysis for 8 week follow-upp-value: 0.66Chi-squared
Comparison: Analysis for 6 month follow up.p-value: 0.37Chi-squared
Comparison: Analysis for 12 month follow up.p-value: 0.19Chi-squared
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
Time frame: 8 weeks, 6 months, 12 months
Population: Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contingency Management | Psychiatric Status | 8 week outcomes | 20.87 units on a scale | Standard Deviation 6.42 |
| Contingency Management | Psychiatric Status | 6 month outcomes | 20.64 units on a scale | Standard Deviation 8.31 |
| Contingency Management | Psychiatric Status | 12 month outcomes | 21.06 units on a scale | Standard Deviation 8.23 |
| Placebo | Psychiatric Status | 8 week outcomes | 18.90 units on a scale | Standard Deviation 6.68 |
| Placebo | Psychiatric Status | 6 month outcomes | 20.19 units on a scale | Standard Deviation 7.42 |
| Placebo | Psychiatric Status | 12 month outcomes | 19.07 units on a scale | Standard Deviation 7.46 |
Comparison: 8 week analysisp-value: 0.015t-test, 2 sided
Comparison: 6 month analysisp-value: 0.45t-test, 2 sided
Comparison: 12 month analysisp-value: 0.0497t-test, 2 sided
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.
Time frame: Baseline to 6 month follow up and 6 month follow up to 12 month follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contingency Management | VHA Healthcare Service Utilization | Total VHA healthcare costs: baseline-6 month f/up | 12744.44 Dollars | Standard Deviation 16321.11 |
| Contingency Management | VHA Healthcare Service Utilization | Total VHA healthcare costs: 6 month-12 month f/up | 8934.52 Dollars | Standard Deviation 13467.21 |
| Placebo | VHA Healthcare Service Utilization | Total VHA healthcare costs: baseline-6 month f/up | 16456.32 Dollars | Standard Deviation 28113.13 |
| Placebo | VHA Healthcare Service Utilization | Total VHA healthcare costs: 6 month-12 month f/up | 8386.94 Dollars | Standard Deviation 13667.4 |
Comparison: Costs for period between 6 month follow-up and 12 month follow up.p-value: >0.05Estimation Equation mean modeling
Comparison: Costs for period between 6 month follow up and 12 month follow up.p-value: >0.05Estimating Equation mean modeling