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Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women
NCT02272023 · View on ClinicalTrials.gov ↗
Study Summary
A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of intensive motivational interviewing (IMI) to standard motivational interviewing techniques (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to IMI or a standard single session of motivational interviewing showed significantly better drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly, mean trajectories for women assigned to IMI showed continuing declines in drinking problems during and after treatment. Differences between study conditions grew larger between 4-month (p\<.05) and 6-month (p\<.01) follow-up and the effect size at 6 months was medium to large (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to respond to the PA's call for studies assessing mechanisms of change. Unlike many previous studies of SMI, we will employ limited exclusion criteria and will enroll participants who present with co-existing drug and psychiatric disorders. Procedures for the proposed study draw from our current successful RCT assessing IMI for methamphetamine (MA) dependence. Successful aspects of the current study include achievement of recruitment goals, strong adherence to the treatment and research protocols, and excellent rates for follow-up interviews (\>90%). The proposed study will take place at the same outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette, California. Participants will include 220 alcohol dependent women who will be randomly assigned to IMI or SMI. Those in SMI will also receive an attention component (nutrition education) to achieve time equivalence between the two study conditions. Participants in both groups will receive standard weekly group treatment offered at the program. In addition, referrals to Alcoholics Anonymous will be provided to all participants. The primary outcomes will be measures of drinking, heavy
Conditions Studied
Interventions
- BEHAVIORAL Intensive Motivational Interviewing
- BEHAVIORAL Single session of Motivational Interviewing
Study Locations (1)
California
- New Leaf Treatment Center — Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-03-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02272023
The ClinicalTrials.gov registry entry for NCT02272023 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Public Health Institute, California, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alcohol Use Disorders appearing as the primary indexed condition, and to 2 interventions — of which Intensive Motivational Interviewing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02272023 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02272023 about?
NCT02272023 is a clinical study titled "Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women". A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of intensive motivational interviewing (IMI) to standard motivational interviewing techniques (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to IMI or a standard single sess...
What is the current status of trial NCT02272023?
This trial is currently completed. It is a NA study. The enrollment target is 215 participants. The study started on 2015-02. Estimated completion is 2019-03-07.
What conditions does trial NCT02272023 study?
This clinical trial studies the following conditions: Alcohol Use Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02272023?
The interventions under investigation include: Intensive Motivational Interviewing (BEHAVIORAL), Single session of Motivational Interviewing (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02272023?
This trial is sponsored by Public Health Institute, California, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02272023 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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