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

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

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.

Study Overview

• Status: Completed
• Conditions: Co-Occurring Alcohol and Drug Misuse
• Intervention / Treatment: Behavioral: CM for Alcohol; Behavioral: CM for drugs; Behavioral: CM for both substances; Behavioral: Non-Contingent group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Self-identify race as American Indian (AI)
2. Are seeking alcohol dependence and drug abuse treatment at a participating reservation
3. Are age 18 or older
4. Meet criteria of DSM-IV diagnosis of current alcohol dependence
5. Current drug misuse
6. Are not pregnant or planning to become pregnant for the duration of the study
7. Are English speaking
8. Have the ability to provide written informed consent

Exclusion Criteria:

1. 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
2. Meet criteria for DSM-IV diagnosis of drug dependence
3. Have significant risk of dangerous drug withdrawal and/or self-reported or medically documented severe withdrawal from drugs in the last 6 months
4. 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
5. Are receiving drugs under the direction of a physician for pain management or another medical condition for which drug abstinence is contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CM for alcohol	Behavioral: CM for Alcohol; 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.
EXPERIMENTAL: CM for drugs	Behavioral: CM for drugs; 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.
EXPERIMENTAL: CM for both substances	Behavioral: CM for both substances; 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.
OTHER: Non-Contingent group; No CM for either substance, the Non-Contingent (NC) group	Behavioral: Non-Contingent group; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures used for descriptive purposes and to assess success of randomization.	We will measure psychopathology with the Brief Symptom Inventory, a self-report instrument that will assess levels of anxiety, depression, impulsiveness, at baseline to characterize the psychiatric severity of the sample that has been used in previous studies of American Indians.	24 weeks
Measures used for descriptive purposes and to assess success of randomization.	The Fagerström Test of Nicotine Dependence will measure the presence and severity of nicotine dependence.	24 weeks
Measures used for descriptive purposes and to assess success of randomization	Interest in alcohol and drug abstinence will be assessed by the Stages of Change Readiness and Treatment Eagerness Scale.	24 weeks
Measures used for descriptive purposes and to assess success of randomization	In addition, other demographic, cultural, and cigarette smoking and alcohol use measures will be administered at baseline. These measures are part of the P20 Center Core measures. These measures include the Veteran's Rand-12 (already gathered as part of this study's protocol), the Behavioral Risk Factor Surveillance System Alcohol Survey, and demographic, cultural, and smoking behaviors (Behavioral Health Cooperative, Core Measures).	24 weeks

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Mike McDonell, PhD, Washington State University

Publications and helpful links

General Publications

• McDonell MG, Skalisky J, Burduli E, Foote A Sr, Granbois A, Smoker K, Hirchak K, Herron J, Ries RK, Echo-Hawk A, Barbosa-Leiker C, Buchwald D, Roll J, McPherson SM. The rewarding recovery study: a randomized controlled trial of incentives for alcohol and drug abstinence with a rural American Indian community. Addiction. 2021 Jun;116(6):1569-1579. doi: 10.1111/add.15349. Epub 2021 Jan 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): September 10, 2018
• Study Completion (ACTUAL): September 10, 2018

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (ESTIMATE): August 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 15, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 13210-001