Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse

Study Overview
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Brief Summary
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Contingency management (CM) is a type of treatment used in the substance abuse field. Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to treatment, contingency management emerged from the behavior therapy traditions in mental health. By most evaluations, contingency management procedures produce one of the largest effect sizes out of all mental health and educational interventions. The purpose of this study is to perform a randomized, controlled trial to evaluate the ability of a culturally-tailored contingency management (CM) intervention to increase alcohol and drug abstinence among American Indian (AI) tribal members from two rural reservations in the Northwest.

Official Title
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P20 Research Project 1 Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse

Conditions
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Co-Occurring Alcohol and Drug Misuse

Intervention / Treatment
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* Behavioral: CM for Alcohol
* Behavioral: CM for drugs
* Behavioral: CM for both substances
* Behavioral: Non-Contingent group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify race as American Indian (AI) Are seeking alcohol dependence and drug abuse treatment at a participating reservation Are age 18 or older Meet criteria of DSM-IV diagnosis of current alcohol dependence Current drug misuse Are not pregnant or planning to become pregnant for the duration of the study Are English speaking Have the ability to provide written informed consent Exclusion Criteria: Have significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure during the last 12 months AND expression of concern by the patient and/or healthcare provider Meet criteria for DSM-IV diagnosis of drug dependence Have significant risk of dangerous drug withdrawal and/or self-reported or medically documented severe withdrawal from drugs in the last 6 months Have any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder, that the Principal Investigator determines would compromise safe study participation Are receiving drugs under the direction of a physician for pain management or another medical condition for which drug abstinence is contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM for alcohol<br>CM for alcohol | Behavioral: CM for Alcohol<br>* Escalating reinforcement for alcohol abstinence. Alcohol-negative CM Participants draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.<br>|
| Experimental: CM for drugs<br>CM for drugs | Behavioral: CM for drugs<br>* Escalating reinforcement for drug abstinence. Drug-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.<br>|
| Experimental: CM for both substances<br>CM for both substances | Behavioral: CM for both substances<br>* Escalating reinforcement for drug and alcohol abstinence. Drug- and alcohol-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.<br>|
| Other: Non-Contingent group<br>No CM for either substance, the Non-Contingent (NC) group | Behavioral: Non-Contingent group<br>* Compensation for Non-Contingent control group participants is dependent only on providing urine samples, regardless of whether the urine tests are negative for alcohol and/or drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified alcohol and/or drug abstinence | At every study visit, urine samples will be collected and analyzed for ethyl glucuronide and drugs. This helps assess Contingency Management as a treatment for alcohol and/or drug dependence. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self- reported data on alcohol and drug use | Measures used for self-reported data on alcohol and drug use: The Alcohol and Drug Timeline Follow Back (TLFB) The Current Opioid Misuse Measure (COMM) The Addiction Severity Index, Native American Version (ASI-NAV) | 24 weeks | 
| Other substance use | Amphetamine, methamphetamine, cocaine, and marijuana, will be measured by the same procedures described for urine tests of alcohol and drug metabolites. | 24 weeks | 
| Self- reported data on health behaviors | We will also collect secondary outcome data on health behaviors that frequently correlate with alcohol and drug misuse with the following measures: The Timeline Follow Back will be used to assess daily number of cigarettes smoked. Brief HIV Risk Behavior Scale Veteran's Rand- 12 Self-Report Services Utilization Assessment | 24 weeks |