Alcohol UsePhase 3NCT00237003
A Brief Alcohol Intervention for Incarcerated Women
A Phase 3 study testing motivational interviewing in people with Alcohol Use and Incarceration, run by Butler Hospital.
Trial summary
The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Alcohol Use, Incarceration
- What is being tested?
- motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Aug 2009
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- incarcerated women
- current hazardous drinking
- current HIV risk behavior
Who cannot join
- -
About this study
The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.
Read the detailed description
Hazardous alcohol use continues to be a problem of major significance throughout the United States. Alcohol use is a prevalent condition that independently acts as an important behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk. The rationale for a brief intervention with incarcerated women who hazardously use alcohol and have HIV risk behaviors is compelling. For such women, we believe that the negative effects of drinking may be increased. An intervention that successfully connects alcohol use with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a person's life, this may improve judgment in pursuing behaviors which risk other negative consequences. Hazardous alcohol, and high-risk drug and sexual activities may be manifestations of a general behavior pattern among incarcerated women, and strategies that engage such individuals are needed. Given the strong association between hazardous alcohol use and high HIV risk sexual and drug activities, interventions that attempt to lower the prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well justified. Brief alcohol interventions have been efficacious in reducing alcohol use across many populations over the past decade.
Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.
- Conditions
- Alcohol Use, Incarceration
- Being tested
- motivational interviewing
- Keywords
- women, incarceration, alcohol use, motivational interviewing
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
| Study group | Role | What they receive |
|---|---|---|
| 1) assessment plus motivational interview | Active comparator | Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation. Receives: Behavioral: motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol use
Measured: 6 months
HIV risk taking
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Michael Stein, M.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237003
- Sponsor's protocol ID
- NIAAASTE14495
- Other IDs
- R01AA014495, NIAAASTE14495
- Status last verified
- May 2010
- First submitted
- 11 Oct 2005
- Last updated
- 12 May 2010
- Results posted
- No
Publications
Hayaki J, Anderson BJ, Stein MD. Sexual risk-taking mediates the association between impulsivity and acquisition of sexually transmitted infections among hazardously drinking incarcerated women. Am J Addict. 2012 Nov;21 Suppl 1(Suppl 1):S63-71. doi: 10.1111/j.1521-0391.2012.00296.x.
PubMed 23786513Caviness CM, Anderson BJ, de Dios MA, Kurth M, Stein M. Prescription medication exchange patterns among methadone maintenance patients. Drug Alcohol Depend. 2013 Jan 1;127(1-3):232-8. doi: 10.1016/j.drugalcdep.2012.07.007. Epub 2012 Jul 31.
PubMed 22854293Caviness CM, Anderson BJ, Stein MD. Prevalence and predictors of sexually transmitted infections in hazardously-drinking incarcerated women. Women Health. 2012;52(2):119-34. doi: 10.1080/03630242.2011.649396.
PubMed 22458289Clarke JG, Anderson BJ, Stein MD. Hazardously drinking women leaving jail: time to first drink. J Correct Health Care. 2011 Jan;17(1):61-8. doi: 10.1177/1078345810385915.
PubMed 21278321Stein MD, Caviness CM, Anderson BJ, Hebert M, Clarke JG. A brief alcohol intervention for hazardously drinking incarcerated women. Addiction. 2010 Mar;105(3):466-75. doi: 10.1111/j.1360-0443.2009.02813.x.
PubMed 20402990Stein MD, Anderson BJ, Caviness CM, Rosengard C, Kiene S, Friedmann P, Clarke JG. Relationship of alcohol use and sexual risk taking among hazardously drinking incarcerated women: an event-level analysis. J Stud Alcohol Drugs. 2009 Jul;70(4):508-15. doi: 10.15288/jsad.2009.70.508.
PubMed 19515290
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Alcohol Intervention for Incarcerated Women
- ClinicalTrials.gov ID
- NCT00237003
- Acronym / sponsor ID
- NIAAASTE14495
- Conditions
- Alcohol Use, Incarceration
- Keywords
- women, incarceration, alcohol use, motivational interviewing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Oct 2005 (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 examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.
Detailed description
Hazardous alcohol use continues to be a problem of major significance throughout the United States. Alcohol use is a prevalent condition that independently acts as an important behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk. The rationale for a brief intervention with incarcerated women who hazardously use alcohol and have HIV risk behaviors is compelling. For such women, we believe that the negative effects of drinking may be increased. An intervention that successfully connects alcohol use with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a person's life, this may improve judgment in pursuing behaviors which risk other negative consequences. Hazardous alcohol, and high-risk drug and sexual activities may be manifestations of a general behavior pattern among incarcerated women, and strategies that engage such individuals are needed. Given the strong association between hazardous alcohol use and high HIV risk sexual and drug activities, interventions that attempt to lower the prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well justified. Brief alcohol interventions have been efficacious in reducing alcohol use across many populations over the past decade.
Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1) assessment plus motivational interview | Active comparator | Behavioral: motivational interviewingParticipants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- incarcerated women
- current hazardous drinking
- current HIV risk behavior
Key exclusion criteria (1 listed)
- -
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 interviewingAssessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation. | Behavioural | 1) assessment plus motivational interview |
Primary outcome
alcohol use
Time frame: 6 months
HIV risk taking
Time frame: 6 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 May 2010.
- Derived from this study: PubMed 23786513Hayaki J, Anderson BJ, Stein MD. Sexual risk-taking mediates the association between impulsivity and acquisition of sexually transmitted infections among hazardously drinking incarcerated women. Am J Addict. 2012 Nov;21 Suppl 1(Suppl 1):S63-71. doi: 10.1111/j.1521-0391.2012.00296.x.
- Derived from this study: PubMed 22854293Caviness CM, Anderson BJ, de Dios MA, Kurth M, Stein M. Prescription medication exchange patterns among methadone maintenance patients. Drug Alcohol Depend. 2013 Jan 1;127(1-3):232-8. doi: 10.1016/j.drugalcdep.2012.07.007. Epub 2012 Jul 31.
- Derived from this study: PubMed 22458289Caviness CM, Anderson BJ, Stein MD. Prevalence and predictors of sexually transmitted infections in hazardously-drinking incarcerated women. Women Health. 2012;52(2):119-34. doi: 10.1080/03630242.2011.649396.
- Derived from this study: PubMed 21278321Clarke JG, Anderson BJ, Stein MD. Hazardously drinking women leaving jail: time to first drink. J Correct Health Care. 2011 Jan;17(1):61-8. doi: 10.1177/1078345810385915.
- Derived from this study: PubMed 20402990Stein MD, Caviness CM, Anderson BJ, Hebert M, Clarke JG. A brief alcohol intervention for hazardously drinking incarcerated women. Addiction. 2010 Mar;105(3):466-75. doi: 10.1111/j.1360-0443.2009.02813.x.
- Derived from this study: PubMed 19515290Stein MD, Anderson BJ, Caviness CM, Rosengard C, Kiene S, Friedmann P, Clarke JG. Relationship of alcohol use and sexual risk taking among hazardously drinking incarcerated women: an event-level analysis. J Stud Alcohol Drugs. 2009 Jul;70(4):508-15. doi: 10.15288/jsad.2009.70.508.
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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.
Michael Stein, M.D. principal investigator
Butler Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing motivational interviewing in people with Alcohol Use and Incarceration, run by Butler Hospital.
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 3 inclusion and 1 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 May 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 6 months). The study lists 2 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 NCT00237003, which also lists 6 linked publications.
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 May 2010.