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NCT02272023 · ClinicalTrials.gov registry record · NA
Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women
A NA study of Alcohol Use Disorders, sponsored by Public Health Institute, California.
- Completed
- Registry status
- NA
- Development phase
- 215
- Enrollment target
- 1
- Study location
NCT02272023: Completed NA study of Alcohol Use Disorders, sponsored by Public Health Institute, California.
NCT02272023 is a NA study of Alcohol Use Disorders that has completed, run by Public Health Institute, California. The registered enrollment target is 215 participants, above the 96-participant average among 8 other Alcohol Use Disorders trials with a reported enrollment target (124% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02272023, a NA study of Alcohol Use Disorders, has completed, sponsored by Public Health Institute, California.
- COMPLETED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Change in daily drinking patterns (quantity and frequency) over the past two months using the Timeline follow-back assessment
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 |
What the finished NCT02272023 record still lists
NCT02272023 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 8 other Alcohol Use Disorders trials with a reported enrollment target (124% higher).
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.
NCT02272023 reports a single indexed study location in California.
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.
What interventions are being tested in trial NCT02272023?
The interventions under investigation include: Intensive Motivational Interviewing (BEHAVIORAL), Single session of Motivational Interviewing (BEHAVIORAL).
Who is sponsoring clinical trial NCT02272023?
This trial is sponsored by Public Health Institute, California, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02272023's enrollment target sits among peer trials
215 1st of 8 higher than 8 of 8 other Alcohol Use Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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