- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01883089
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
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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