Alcohol AbuseNCT02986776
Treatment Settings for Those With an Alcohol Problem
A study testing Inpatient Care and Outpatient Care in people with Alcohol Abuse and Alcohol-dependence, run by State University of New York at Buffalo.
Trial summary
A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol-dependence
- What is being tested?
- Inpatient Care and Outpatient Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Apr 2008
- 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
- Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
- Drank alcoholic beverages within the last 90 days
- Have a current address (not homeless)
- Free of legal stipulations that would affect treatment decisions
- Have a past 3 months Alcohol Use Disorder
- Primary alcohol, or alcohol and drug problem
Who cannot join
- Homeless
- Drug problem only
About this study
Official title: Treatment Settings for Alcoholics: A Field Extension
A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted an 90-day intervals across 18 months.
- Conditions
- Alcohol Abuse, Alcohol-dependence
- Being tested
- Inpatient Care, Outpatient Care
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient CareBehavioural
21 days of inpatient substance misuse treatment
Outpatient CareBehavioural
21 days of outpatient substance misuse treatment
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Care + Needs Inpatient | Active comparator | Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment Receives: Behavioral: Inpatient Care |
| Inpatient Care + No Need for Inpatient | Active comparator | Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment Receives: Behavioral: Inpatient Care |
| Outpatient Care + Needs Inpatient | Active comparator | Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment Receives: Behavioral: Outpatient Care |
| Outpatient Care + No Need for Inpatient | Active comparator | Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment Receives: Behavioral: Outpatient Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
Percentage of Days Abstinent of those in which drinking was not restricted
Measured: Change up to 18 months
Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
Monthly percentage of participants abstinent throughout a month
Measured: Change up to 18 months
Monthly Drinks per Drinking Day (from Timeline Followback Interview)
For those drinking in a month, average drinks per drinking day
Measured: Change up to 18 months
Secondary outcomes (1)
Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startAug 2002
- Primary completionApr 2008
- Study completionApr 2008
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 Alcohol AbuseStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Rychtarik, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986776
- Sponsor's protocol ID
- AA013625
- Status last verified
- Oct 2020
- First submitted
- 6 Dec 2016
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rychtarik RG, McGillicuddy NB, Papandonatos GD, Whitney RB, Connors GJ. Randomized clinical trial of matching client alcohol use disorder severity and level of cognitive functioning to treatment setting: A partial replication and extension. Psychol Addict Behav. 2017 Aug;31(5):513-523. doi: 10.1037/adb0000253. Epub 2017 Feb 2.
PubMed 28150955
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Settings for Alcoholics: A Field Extension
- ClinicalTrials.gov ID
- NCT02986776
- Acronym / sponsor ID
- AA013625
- Conditions
- Alcohol Abuse, Alcohol-dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Dec 2016 (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.
A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted an 90-day intervals across 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inpatient Care + Needs Inpatient | Active comparator | Behavioral: Inpatient CareIndividuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment |
| Inpatient Care + No Need for Inpatient | Active comparator | Behavioral: Inpatient CareIndividuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment |
| Outpatient Care + Needs Inpatient | Active comparator | Behavioral: Outpatient CareIndividuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment |
| Outpatient Care + No Need for Inpatient | Active comparator | Behavioral: Outpatient CareIndividuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
- Drank alcoholic beverages within the last 90 days
- Have a current address (not homeless)
- Free of legal stipulations that would affect treatment decisions
- Have a past 3 months Alcohol Use Disorder
Key exclusion criteria (2 listed)
- Homeless
- Drug problem only
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 |
|---|---|---|
| Inpatient Care21 days of inpatient substance misuse treatment | Behavioural | Inpatient Care + Needs Inpatient, Inpatient Care + No Need for Inpatient |
| Outpatient Care21 days of outpatient substance misuse treatment | Behavioural | Outpatient Care + Needs Inpatient, Outpatient Care + No Need for Inpatient |
Primary outcome
Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
Time frame: Change up to 18 months
Percentage of Days Abstinent of those in which drinking was not restricted
Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
Time frame: Change up to 18 months
Monthly percentage of participants abstinent throughout a month
Monthly Drinks per Drinking Day (from Timeline Followback Interview)
Time frame: Change up to 18 months
For those drinking in a month, average drinks per drinking day
1 secondary outcome
Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
Time frame: Up to 18 months
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 12 Oct 2020.
- Derived from this study: PubMed 28150955Rychtarik RG, McGillicuddy NB, Papandonatos GD, Whitney RB, Connors GJ. Randomized clinical trial of matching client alcohol use disorder severity and level of cognitive functioning to treatment setting: A partial replication and extension. Psychol Addict Behav. 2017 Aug;31(5):513-523. doi: 10.1037/adb0000253. Epub 2017 Feb 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient Care and Outpatient Care in people with Alcohol Abuse and Alcohol-dependence, run by State University of New York at Buffalo.
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 6 inclusion and 2 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview) (time frame: Change up to 18 months). The study lists 3 primary outcomes in all. 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 NCT02986776, 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 12 Oct 2020.