Alcohol DependenceNCT01883089
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
A study testing Motivational Enhancement Therapy in people with Alcohol Dependence, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Dependence
- Being tested
- Motivational Enhancement Therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Motivational Enhancement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per day
Drinks consumed per day will be monitored daily over 90 days using interactive voice response systems (i.e., telephone call in).
Measured: participants will be followed for the duration of the study, an expected average of 90 days
Secondary outcomes (2)
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).
Measured: participants will be followed for the duration of the study, an expected average of 90 days
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).
Measured: participants will be followed for the duration of the study, an expected average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Schlauch, University of South Florida
- Investigators
- Robert C Schlauch, Phd, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883089
- Sponsor's protocol ID
- Craving and Drinking
- Status last verified
- May 2017
- First submitted
- 17 Jun 2013
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38010773
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
- ClinicalTrials.gov ID
- NCT01883089
- Acronym / sponsor ID
- Craving and Drinking
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other | Other | Behavioral: Motivational Enhancement TherapyParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement Therapy | Behavioural | Other |
Primary outcome
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).
2 secondary outcomes
Approach inclinations
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 38010773Walsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Schlauch, Phd principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy in people with Alcohol Dependence, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks per day (time frame: participants will be followed for the duration of the study, an expected average of 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.