Alcohol Use DisorderPhase 2NCT00561041
Aftercare for Adolescents Treated for Alcohol Abuse and Dependence
A Phase 2 study testing Brief phone aftercare intervention and individual aftercare therapy in people with Alcohol Use Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD) Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brief phone aftercare intervention and individual aftercare therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2006
- Phase
- Phase 2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between the ages of 13-18 years
- Meeting criteria for DSM-IV alcohol use disorders
- Able to comprehend and read English at the 5th grade level
- Participant and family member are willing to provide a locator information.
- Not planning to move out of state during the next 12 months
Who cannot join
- Meet any substance dependence criteria other than nicotine or cannabis
- Meet life time diagnosis of schizophrenia
- Reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days
- Having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Maintenance of Treatment Gains in Adolescents With Alcohol Related Disorders
The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)
Read the detailed description
In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (AR) conditions noted above. Manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC completion.
- Conditions
- Alcohol Use Disorder
- Being tested
- Brief phone aftercare intervention, individual aftercare therapy
- Keywords
- alcohol, alcohol use disorder, cognitive-behavioral therapy, brief phone aftercare intervention, individual aftercare therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief phone aftercare interventionBehavioural
Interventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule
individual aftercare therapyBehavioural
composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief phone aftercare intervention composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule Receives: Behavioral: Brief phone aftercare intervention |
| 2 | Experimental | Individual aftercare therapy - composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule Receives: Behavioral: individual aftercare therapy |
| 3 | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use (days of use and days of heavy drinking)
Measured: 3, 6, and 12 months post aftercare condition completion
Secondary outcomes (1)
Drug use according to primary outcome timeframe
Measured: 3, 6, and 12 months post aftercare condition completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Yifrah Kaminer, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561041
- Sponsor's protocol ID
- NIAAA_KAM_012187
- Other IDs
- NIH grant number RO1-AA012187
- Status last verified
- Nov 2007
- First submitted
- 19 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Treatment Gains in Adolescents With Alcohol Related Disorders
- ClinicalTrials.gov ID
- NCT00561041
- Acronym / sponsor ID
- NIAAA_KAM_012187
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol, alcohol use disorder, cognitive-behavioral therapy, brief phone aftercare intervention, individual aftercare therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Nov 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Nov 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 study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)
Detailed description
In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (AR) conditions noted above. Manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief phone aftercare interventionBrief phone aftercare intervention composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule |
| 2 | Experimental | Behavioral: individual aftercare therapyIndividual aftercare therapy - composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule |
| 3 | No intervention | –No intervention |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents between the ages of 13-18 years
- Meeting criteria for DSM-IV alcohol use disorders
- Able to comprehend and read English at the 5th grade level
- Participant and family member are willing to provide a locator information.
- Not planning to move out of state during the next 12 months
Key exclusion criteria (4 listed)
- Meet any substance dependence criteria other than nicotine or cannabis
- Meet life time diagnosis of schizophrenia
- Reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days
- Having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare
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 phone aftercare interventionInterventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule | Behavioural | 1 |
| individual aftercare therapycomposed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule | Behavioural | 2 |
Primary outcome
Alcohol use (days of use and days of heavy drinking)
Time frame: 3, 6, and 12 months post aftercare condition completion
1 secondary outcome
Drug use according to primary outcome timeframe
Time frame: 3, 6, and 12 months post aftercare condition completion
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 20 Nov 2007.
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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.
Yifrah Kaminer, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief phone aftercare intervention and individual aftercare therapy in people with Alcohol Use Disorder, 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 5 inclusion and 4 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 20 Nov 2007. 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 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.
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 (days of use and days of heavy drinking) (time frame: 3, 6, and 12 months post aftercare condition completion). 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 20 Nov 2007.