Back to resultsAmbivalence Model of Craving: Re-examining the Drinking-craving Relationship
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
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
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Other
Arm Description
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).
Outcomes
Primary Outcome Measures
Drinks per day
Drinks consumed per day will be monitored daily over 90 days using interactive voice response systems (i.e., telephone call in).
Secondary Outcome Measures
Approach inclinations
Approach inclinations (desires to use alcohol) will be collected daily over 90 days using interactive voice response systems (i.e., telephone call in).
Avoidance inclinations
Avoidance inclinations (desires to not use alcohol) will be collected daily over 90 days using interactive voice response systems (i.e., telephone call in).
Full Information
NCT ID
NCT01883089
First Posted
June 17, 2013
Last Updated
May 16, 2017
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT01883089
Brief Title
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
Official Title
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Other
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Primary Outcome Measure Information:
Title
Drinks per day
Description
Drinks consumed per day will be monitored daily over 90 days using interactive voice response systems (i.e., telephone call in).
Time Frame
participants will be followed for the duration of the study, an expected average of 90 days
Secondary Outcome Measure Information:
Title
Approach inclinations
Description
Approach inclinations (desires to use alcohol) will be collected daily over 90 days using interactive voice response systems (i.e., telephone call in).
Time Frame
participants will be followed for the duration of the study, an expected average of 90 days
Title
Avoidance inclinations
Description
Avoidance inclinations (desires to not use alcohol) will be collected daily over 90 days using interactive voice response systems (i.e., telephone call in).
Time Frame
participants will be followed for the duration of the study, an expected average of 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Schlauch, Phd
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
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