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Alcohol DependencePhase 1IATPNCT00298792

Individualized Treatment Program for Alcohol Problems

A Phase 1 study testing Cognitive Behavioral Treatment and Cognitive-behavioral treatment in people with Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
Cognitive Behavioral Treatment and Cognitive-behavioral treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
Jan 2006to Apr 2008
Phase
Phase 1
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
  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

Other trials in United States

About this study

The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments.

Read the detailed description

Despite the popularity of Cognitive-Behavioral Treatment (CBT) in substance use disorders, recent findings have indicated that CBT may be no more effective than other, less theoretically driven, treatments, and that CBT treatments often fail to result in coping skills acquisition. In order to explore the possibility that current manual-driven modes of CBT delivery may not be adequate to successfully teach coping skills, we are proposing a pilot project for the development of an individualized assessment and cognitive-behavioral treatment program (IATP) for alcohol-dependent persons, in which experience sampling conducted via random calls to cell-phones is used to provide data to create individualized treatment plans. Data collected during experience sampling will include momentary assessments of patients' cognitions, affects, and coping behaviors with respect to drinking.

Participants will be 112 men and women meeting criteria for alcohol dependence, who will be randomly assigned to either a standard packaged manual-driven cognitive-behavioral treatment program (PCBT) like that used in Project MATCH, or to IATP. Patients in both treatments will be asked to engage in experience sampling for two weeks prior to treatment, and for another two weeks after treatment has ended, in order to compare in-vivo measures of coping skills utilization, pre- and posttreatment, between the two groups. Therapy will be conducted over 12 sessions in both treatments. In IATP, the information gathered from experience sampling will form the basis of a functional analysis of patients' drinking and drinking urges during the monitoring period. Cognitive appraisals, moods and coping responses will be evaluated as antecedents and consequences of drinking behavior. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will work with the patient to substitute adaptive coping tactics instead. In PCBT the experience sampling data will not be specifically used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP will yield significantly better coping skills acquisition than will PCBT, and that change in coping skills will predict better posttreatment outcomes for IATP. These results would have implications for our delivery of treatment, and for the validity of coping skills training for alcohol addiction.

Being tested
Cognitive Behavioral Treatment, Cognitive-behavioral treatment
Keywords
Cognitive Behavioral Treatment, Alcohol Dependence, Functional Analysis, Experience Sampling, Interactive Voice Response
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TreatmentBehavioural

    Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.

  • Cognitive-behavioral treatmentBehavioural

    Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

Study groups in NCT00298792
Study groupRoleWhat they receive
Individualized Assessment & treatmentExperimentalIndividualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.
Receives: Behavioral: Cognitive Behavioral Treatment; Behavioral: Cognitive-behavioral treatment
Packaged Cognitive-Behavioral TreatmentActive comparatorManualized cognitive-behavioral treatment for alcohol dependent persons.
Receives: Behavioral: Cognitive Behavioral Treatment; Behavioral: Cognitive-behavioral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol consumption

    Measured: Pre - Post

Secondary outcomes (1)
  1. Alcohol-related life problems

    Measured: Pre - Post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00298792
Sponsor's protocol ID
NIAAALIT014202-02
Other IDs
NIH grant 1 R21 AA14202
Acronym
IATP
Status last verified
Apr 2009
First submitted
1 Mar 2006
Last updated
15 Apr 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cognitive Behavioral Treatment and Cognitive-behavioral treatment in people with Alcohol Dependence, 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: finished, as of the sponsor's last update on 15 Apr 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 consumption (time frame: Pre - Post). 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 15 Apr 2009.

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Individualized Treatment Program for Alcohol Problems | AzTrials