AlcoholismNCT02409888
Evaluating Interventions for Alcohol Use Disorder
A study testing Motivational Enhancement Therapy, Cognitive Behavioral Therapy and FC Assessment in people with Alcoholism, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Motivational Enhancement Therapy, Cognitive Behavioral Therapy and FC Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Jul 2021
- 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
None listed.
Who cannot join
- Individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, IV drug use),
- a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the DIS-IV will be precluded from study participation.
- In addition,
- individuals reporting current enrollment in a substance abuse treatment program,
- mandated to substance abuse treatment by a court order, or
- severely socially unstable (e.g., homeless) also will be precluded from study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University School of Public Health
New Brunswick, New Jersey, 08901
About this study
The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.
- Conditions
- Alcoholism
- Being tested
- Motivational Enhancement Therapy, Cognitive Behavioral Therapy, FC Assessment, IB Assessment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement TherapyBehavioural
The motivational enhancement therapy will be delivered according to the Project MATCH manual.
Cognitive Behavioral TherapyBehavioural
The cognitive behavioral therapy will be delivered according to the Project MATCH manual.
FC AssessmentOther
FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.
IB AssessmentOther
IB Assessment study participants are exposed to semi-annual alcohol specific assessments
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Study participants receive either motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT). Receives: Behavioral: Motivational Enhancement Therapy; Behavioral: Cognitive Behavioral Therapy |
| Assessment | Experimental | IB Assessment study participants receive semi-annual assessments specific to their alcohol and other drug use and FC Assessment study participants receive quarterly assessments specific to diverse areas of functioning (e.g., alcohol and other drug use, social, occupational, legal, psychological/psychiatric, marital). Receives: Other: FC Assessment; Other: IB Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
Alcohol use will be measured as percent days abstinent, mean drinks per drinking day, and percent heavy drinking days for study months 3 - 15 (one year post-treatment).
Measured: One year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Syracuse University, Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Patrick R. Clifford (PI), Rutgers, The State University of New Jersey
- Investigators
- Patrick R Clifford, PhD, Principal investigator, Rutgers University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409888
- Sponsor's protocol ID
- Pro2013003944
- Other IDs
- 1R01AA022330-01A1
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2015
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Interventions for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT02409888
- Acronym / sponsor ID
- Pro2013003944
- Conditions
- Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Syracuse University, Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 7 Apr 2015 (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.
The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational Enhancement Therapy, Behavioral: Cognitive Behavioral TherapyStudy participants receive either motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT). |
| Assessment | Experimental | Other: FC Assessment, Other: IB AssessmentIB Assessment study participants receive semi-annual assessments specific to their alcohol and other drug use and FC Assessment study participants receive quarterly assessments specific to diverse areas of functioning (e.g., alcohol and other drug use, social, occupational, legal, psychological/psychiatric, marital). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, IV drug use),
- a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the DIS-IV will be precluded from study participation.
- In addition,
- individuals reporting current enrollment in a substance abuse treatment program,
- mandated to substance abuse treatment by a court order, or
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 |
|---|---|---|
| Motivational Enhancement TherapyThe motivational enhancement therapy will be delivered according to the Project MATCH manual. | Behavioural | Intervention |
| Cognitive Behavioral TherapyThe cognitive behavioral therapy will be delivered according to the Project MATCH manual. | Behavioural | Intervention |
| FC AssessmentFC Assessment study participants are exposed to quarterly assessments across broad domains of functioning. | Other | Assessment |
| IB AssessmentIB Assessment study participants are exposed to semi-annual alcohol specific assessments | Other | Assessment |
Primary outcome
Alcohol Use
Time frame: One year post-treatment
Alcohol use will be measured as percent days abstinent, mean drinks per drinking day, and percent heavy drinking days for study months 3 - 15 (one year post-treatment).
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 19 Aug 2021.
Related trials for Alcoholism
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Recruiting
Coordinated Care for Alcohol Problems
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Enrolling by invitationObservational study
Addictions Neuroclinical Assessment (ANA)
Normal Physiology, Alcohol Use Disorder
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.
Patrick R Clifford, PhD principal investigator
Rutgers University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy, Cognitive Behavioral Therapy and FC Assessment in people with Alcoholism, run by Rutgers, The State University of New Jersey 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 0 inclusion and 6 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 19 Aug 2021. 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?
Alcohol Use (time frame: One year post-treatment). 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 19 Aug 2021.