NCT01883089

Brief Summary

The current study combines both clinical trial and daily process methodology to examine the dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e., craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily avoidance inclinations will significantly moderate the effect of daily approach inclinations on drinking behaviors, and that significant increases in avoidance inclinations will be observed prior to treatment entry, followed by significant decreases in approach inclinations during treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

June 17, 2013

Last Update Submit

May 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Drinks per day

    Drinks consumed per day will be monitored daily over 90 days using interactive voice response systems (i.e., telephone call in).

    participants will be followed for the duration of the study, an expected average of 90 days

Secondary Outcomes (2)

  • Approach inclinations

    participants will be followed for the duration of the study, an expected average of 90 days

  • Avoidance inclinations

    participants will be followed for the duration of the study, an expected average of 90 days

Study Arms (1)

Other

OTHER

Participants will be recruited to complete a 90 day daily monitoring study during which time will be invited to participate in a 4 week brief alcohol intervention during days 31-60 (i.e., second month).

Behavioral: Motivational Enhancement Therapy

Interventions

Eligibility Criteria

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

You may qualify if:

  • current diagnosis of alcohol dependence
  • live within commuting distance of the program site,
  • regular access to a phone to call into an IVR system and
  • provide informed consent

You may not qualify if:

  • acute psychosis or severe cognitive impairment
  • current or previous treatment for an alcohol use disorder within the past 6 months,
  • taking medications that may modify alcohol use,
  • current drug use diagnosis other than nicotine or marijuana abuse,
  • lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures, and
  • legally mandated to attend treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

Related Publications (1)

  • Walsh BE, Dvorak RD, Ebbinghaus A, Gius BK, Levine JA, Cortina W, Schlauch RC. Disaggregating within- and between-person effects of affect on drinking behavior in a clinical sample with alcohol use disorder. J Psychopathol Clin Sci. 2023 Nov;132(8):1051-1059. doi: 10.1037/abn0000875.

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Robert C Schlauch, Phd

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 21, 2013

Study Start

January 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations