Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship

May 16, 2017 updated by: Robert Schlauch, University of South Florida
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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tampa, Florida, United States, 33620
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per day
Time Frame: participants will be followed for the duration of the study, an expected average of 90 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Approach inclinations
Time Frame: participants will be followed for the duration of the study, an expected average of 90 days
Approach inclinations (desires to use alcohol) will be collected 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
Avoidance inclinations
Time Frame: participants will be followed for the duration of the study, an expected average of 90 days
Avoidance inclinations (desires to not use alcohol) will be collected 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert C Schlauch, Phd, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (ESTIMATE)

June 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Craving and Drinking

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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