Alcohol AbuseCMETGNCT01567943
Contingency Management of Alcohol Abuse in the Severely Mentally ILL
A study testing Contingency Management in people with Alcohol Abuse and Schizophrenia, run by University of Washington at 1 site in United States.
Trial summary
The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse, Schizophrenia, Bipolar Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
- Aged 18 to 65 years.
- Ability to understand written and spoken English language.
- DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
- Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview.
- Alcohol use in the month prior to study entry: self-reported alcohol use of 5 days or more during the 30 days prior to study entry (5 drinking days/month is selected based on previous research reporting alcohol use in 18% of days assessed in a sample of psychiatric outpatients with co-occurring SUDs \& SMI).120
- A CPC treating clinician must affirm the potential participant is safe to participate in the study.
Who cannot join
- A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal.
- DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
- Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
- Chart defined organic brain disorder or dementia.
- Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98014
About this study
Official title: Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.
Read the detailed description
The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions.
The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.
- Being tested
- Contingency Management
- Keywords
- alcohol abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment
- Medical subject headings
- Alcoholism, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Behavioral reinforcement for alcohol abstinence
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Contingency Management plus treatment as usual Receives: Behavioral: Contingency Management |
| Non-contingent control group | No intervention | Treatment as usual plus reinforcement for attendance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine
Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.
Measured: Over 16 weeks of treatment (repeated measure)
Secondary outcomes (5)
Change in Intensive Outpatient Substance Abuse Treatment Attendance
Measured: During 16 weeks of treatment
Self Report Drug Use
Measured: through 7 months of study
Other Drug Use as Measured by Urinalysis
Measured: through 7 months of study
Community Outcomes
(jail bookings, ER visits, mental health and substance abuse service utilization)
Measured: entire study period, and three month prior and after study involvement
Psychiatric Symptomology
Brief Symptom Inventory; Positive and Negative Symptom Scale
Measured: throughout 7 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Ries, University of Washington
- Investigators
- Richard K Ries, MD, Principal investigator, University of WashingtonMichael McDonell, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567943
- Sponsor's protocol ID
- 41552-G
- Acronym
- CMETG
- Status last verified
- Jan 2017
- First submitted
- 26 Mar 2012
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
- ClinicalTrials.gov ID
- NCT01567943
- Acronym / sponsor ID
- CMETG / 41552-G
- Keywords
- alcohol abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.
Detailed description
The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions.
The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementContingency Management plus treatment as usual |
| Non-contingent control group | No intervention | –Treatment as usual plus reinforcement for attendance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
- Aged 18 to 65 years.
- Ability to understand written and spoken English language.
- DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
- Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview.
Key exclusion criteria (5 listed)
- A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal.
- DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
- Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
- Chart defined organic brain disorder or dementia.
- Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.
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 |
|---|---|---|
| Contingency ManagementBehavioral reinforcement for alcohol abstinence | Behavioural | Contingency Management |
Primary outcome
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine
Time frame: Over 16 weeks of treatment (repeated measure)
Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.
5 secondary outcomes
Change in Intensive Outpatient Substance Abuse Treatment Attendance
Time frame: During 16 weeks of treatment
Self Report Drug Use
Time frame: through 7 months of study
Other Drug Use as Measured by Urinalysis
Time frame: through 7 months of study
Community Outcomes
Time frame: entire study period, and three month prior and after study involvement
Psychiatric Symptomology
Time frame: throughout 7 months of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Richard K Ries, MD principal investigator
University of Washington
Michael 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 Contingency Management in people with Alcohol Abuse and Schizophrenia, run by University of Washington 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 7 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 23 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine (time frame: Over 16 weeks of treatment (repeated measure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.