NCT00298792

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

2.2 years

First QC Date

March 1, 2006

Last Update Submit

April 14, 2009

Conditions

Alcohol Dependence

Keywords

Cognitive Behavioral TreatmentAlcohol DependenceFunctional AnalysisExperience SamplingInteractive Voice Response

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption

    Pre - Post

Secondary Outcomes (1)

  • Alcohol-related life problems

    Pre - Post

Study Arms (2)

Individualized Assessment & treatment

EXPERIMENTAL

Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.

Behavioral: Cognitive Behavioral TreatmentBehavioral: Cognitive-behavioral treatment

Packaged Cognitive-Behavioral Treatment

ACTIVE COMPARATOR

Manualized cognitive-behavioral treatment for alcohol dependent persons.

Behavioral: Cognitive Behavioral TreatmentBehavioral: Cognitive-behavioral treatment

Interventions

Cognitive Behavioral TreatmentBEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.

Individualized Assessment & treatmentPackaged Cognitive-Behavioral Treatment
Cognitive-behavioral treatmentBEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

Individualized Assessment & treatmentPackaged Cognitive-Behavioral Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark D. Litt, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

US(1)