Co-Occurring Alcohol and Drug MisuseNCT02222389
Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse
A study testing CM for Alcohol, CM for drugs and CM for both substances in people with Co-Occurring Alcohol and Drug Misuse, run by Washington State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Co-Occurring Alcohol and Drug Misuse
- What is being tested?
- CM for Alcohol, CM for drugs and CM for both substances
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Co-Occurring Alcohol and Drug Misuse
- Being tested
- CM for Alcohol, CM for drugs, CM for both substances, Non-Contingent group
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM for AlcoholBehavioural
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 drugsBehavioural
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 substancesBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CM for alcohol | Experimental | CM for alcohol Receives: Behavioral: CM for Alcohol |
| CM for drugs | Experimental | CM for drugs Receives: Behavioral: CM for drugs |
| CM for both substances | Experimental | CM for both substances Receives: Behavioral: CM for both substances |
| Non-Contingent group | Other | No CM for either substance, the Non-Contingent (NC) group Receives: Behavioral: Non-Contingent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start1 Jun 2015
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Co-Occurring Alcohol and Drug MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McDonell, Washington State University
- Investigators
- Mike McDonell, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222389
- Sponsor's protocol ID
- 13210-001
- Status last verified
- Sep 2018
- First submitted
- 22 Jul 2014
- Last updated
- 18 Sep 2018
- Results posted
- No
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.
PubMed 33220122
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P20 Research Project 1 Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse
- ClinicalTrials.gov ID
- NCT02222389
- Acronym / sponsor ID
- 13210-001
- Conditions
- Co-Occurring Alcohol and Drug Misuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CM for alcohol | Experimental | Behavioral: CM for AlcoholCM for alcohol |
| CM for drugs | Experimental | Behavioral: CM for drugsCM for drugs |
| CM for both substances | Experimental | Behavioral: CM for both substancesCM for both substances |
| Non-Contingent group | Other | Behavioral: Non-Contingent groupNo CM for either substance, the Non-Contingent (NC) group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM for AlcoholEscalating 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. | Behavioural | CM for alcohol |
| CM for drugsEscalating 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. | Behavioural | CM for drugs |
| CM for both substancesEscalating 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. | Behavioural | CM for both substances |
| Non-Contingent groupCompensation 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. | Behavioural | Non-Contingent group |
Primary outcome
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.
3 secondary outcomes
Self- reported data on alcohol and drug use
Time frame: 24 weeks
Other substance use
Time frame: 24 weeks
Self- reported data on health behaviors
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 33220122McDonell 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike McDonell, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM for Alcohol, CM for drugs and CM for both substances in people with Co-Occurring Alcohol and Drug Misuse, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified alcohol and/or drug abstinence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.