Alcohol DrinkingPhase 2/3NCT00547963
Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use
A Phase 2/3 study testing brief counseling in people with Alcohol Drinking and Marijuana Smoking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Marijuana Smoking
- What is being tested?
- brief counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2008
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients 18 years of age or older.
- Participants will have a current DSM-IV diagnosis of alcohol dependence.
- Participants will have signed a witnessed informed consent.
Who cannot join
- Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
- Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Injury Prevention Center, Rhode Island Hospital, Brown University
Providence, Rhode Island, 02903
About this study
Official title: Reducing Injury, ETOH and THC Use Among ED Patients
The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.
Read the detailed description
Alcohol and substance use remain a significant predictor of injuries, health and psychosocial consequences.
ED patients who were not being treated for critical conditions were asked about their use of alcohol and marijuana. Patients who self-reported the use of both substances were asked to participate in the study.
Recruited participants were given a baseline assessment and then randomized a treatment or a control condition. The treatment condition consisted of two 40 minute sessions of brief counseling. The first session took place in the ED the second session occurred within two weeks of being seen in the ED.
Participants completed assessments three and twelve months after being recruited in the ED. The primary dependent variables for this study are 12 month injuries and self-reported levels of negative life consequences associated with alcohol and marijuana use.
- Conditions
- Alcohol Drinking, Marijuana Smoking
- Being tested
- brief counseling
- Keywords
- Alcohol Drinking, Marijuana Smoking, Substance Use, Emergency Department (ED)
- Medical subject headings
- Alcohol Drinking, Marijuana Smoking, Substance-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief counselingBehavioural
baseline assessment + two 40 minute sessions of brief counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | two brief counseling sessions delivered to ED patients who report conjoint alcohol and marijuana use Receives: Behavioral: brief counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use; injuries, alcohol and marijuana negative consequences
Measured: 3 and 12 months
Secondary outcomes (1)
Mediators and moderators of treatment efficacy
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startDec 2003
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Janette Baird, PhD, Principal investigator, Injury Prevention Center, Rhode Island Hospital, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547963
- Sponsor's protocol ID
- NIAAA-BAI-013709
- Other IDs
- NIH Grant number 5R01AA013709
- Status last verified
- Oct 2008
- First submitted
- 19 Oct 2007
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Injury, ETOH and THC Use Among ED Patients
- ClinicalTrials.gov ID
- NCT00547963
- Acronym / sponsor ID
- NIAAA-BAI-013709
- Conditions
- Alcohol Drinking, Marijuana Smoking
- Keywords
- Alcohol Drinking, Marijuana Smoking, Substance Use, Emergency Department (ED)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 554 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Dec 2003
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 23 Oct 2007 (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 determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.
Detailed description
Alcohol and substance use remain a significant predictor of injuries, health and psychosocial consequences.
ED patients who were not being treated for critical conditions were asked about their use of alcohol and marijuana. Patients who self-reported the use of both substances were asked to participate in the study.
Recruited participants were given a baseline assessment and then randomized a treatment or a control condition. The treatment condition consisted of two 40 minute sessions of brief counseling. The first session took place in the ED the second session occurred within two weeks of being seen in the ED.
Participants completed assessments three and twelve months after being recruited in the ED. The primary dependent variables for this study are 12 month injuries and self-reported levels of negative life consequences associated with alcohol and marijuana use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: brief counselingtwo brief counseling sessions delivered to ED patients who report conjoint alcohol and marijuana use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female outpatients 18 years of age or older.
- Participants will have a current DSM-IV diagnosis of alcohol dependence.
- Participants will have signed a witnessed informed consent.
Key exclusion criteria (2 listed)
- Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
- Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
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 |
|---|---|---|
| brief counselingbaseline assessment + two 40 minute sessions of brief counseling | Behavioural | 1 |
Primary outcome
Substance use; injuries, alcohol and marijuana negative consequences
Time frame: 3 and 12 months
1 secondary outcome
Mediators and moderators of treatment efficacy
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
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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.
Janette Baird, PhD principal investigator
Injury Prevention Center, Rhode Island Hospital, Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing brief counseling in people with Alcohol Drinking and Marijuana Smoking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2008. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Substance use; injuries, alcohol and marijuana negative consequences (time frame: 3 and 12 months). 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 8 Oct 2008.