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Completed

NCT Number: NCT02222389

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.

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Key information

Conditions

Co-Occurring Alcohol and Drug Misuse Chemically-Induced Disorders Drug Misuse Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

Spokane, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM for Alcohol

Behavioral

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.

CM for drugs

Behavioral

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.

CM for both substances

Behavioral

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.

Non-Contingent group

Behavioral

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.

Primary outcomes

  1. Biochemically verified alcohol and/or drug abstinence

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Self- reported data on alcohol and drug use

    Time frame: 24 weeks

    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)

  2. Other substance use

    Time frame: 24 weeks

    Amphetamine, methamphetamine, cocaine, and marijuana, will be measured by the same procedures described for urine tests of alcohol and drug metabolites.

  3. Self- reported data on health behaviors

    Time frame: 24 weeks

    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

Other outcomes

  1. Measures used for descriptive purposes and to assess success of randomization.

    Time frame: 24 weeks

    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.

  2. Measures used for descriptive purposes and to assess success of randomization.

    Time frame: 24 weeks

    The Fagerström Test of Nicotine Dependence will measure the presence and severity of nicotine dependence.

  3. Measures used for descriptive purposes and to assess success of randomization

    Time frame: 24 weeks

    Interest in alcohol and drug abstinence will be assessed by the Stages of Change Readiness and Treatment Eagerness Scale.

  4. Measures used for descriptive purposes and to assess success of randomization

    Time frame: 24 weeks

    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).

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2014
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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