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CompletedNCT02642757Updated May 22, 2019

Alcohol Brief Counseling in Primary Care

An interventional study of AUDIT brief intervention and Pamphlet on alcohol use in Alcohol Drinking, sponsored by Pontificia Universidad Catolica de Chile. Completed at 5 sites in Chile. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-22.

Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
342
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.

Read the detailed description

Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.

The brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide.

The implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror.

Randomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box.

Data will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile.

Bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit.

The participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.

02

Conditions studied

  • Alcohol Drinking

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Keywords

  • alcohol drinking
  • hazardous alcohol use
  • risky alcohol consumption
  • heavy alcohol consumption
03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 342 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • AUDIT score between 8 and 15
  • Able to read
  • Haven't received a similar intervention in the last 3 months

Exclusion criteria

Exclusion Criteria:

  • Clients in treatment for alcohol use disorder
  • Alcohol use treatment seekers
  • Pregnant woman
  • Severe physical or psychiatric pathology not stable
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
342 participants (actual)

Study arms

  • Experimental
    Brief intervention

    AUDIT brief intervention

    Behavioral: AUDIT brief intervention · Other: Pamphlet on alcohol use

  • Sham comparator
    Control group

    Pamphlet on alcohol use

    Other: Pamphlet on alcohol use

Interventions

  • BehavioralAUDIT brief intervention

    Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.

  • OtherPamphlet on alcohol use

    Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.

06

What researchers measure

Primary outcomes

  1. AUDIT score

    Total of questions 1 to 10 (minimum 0, maximum 40)

    Time frame: 6 months post brief intervention

Secondary outcomes

  1. AUDIT-C score

    Total of questions 1 to 3 (minimum 0, maximum 12)

    Time frame: 6 months post brief intervention

07

Study locations

5 sites
  • CESFAM Juan Pablo II
    Santiago, Metropolitana, Chile
  • CESFAM San Alberto Hurtado
    Santiago, Puente Alto 8181297, Chile
  • CESFAM Madre Teresa de Calcuta
    Santiago, Puente Alto, Chile
  • CESFAM Barros Luco
    Santiago, San Miguel, Chile
  • CESFAM Recreo
    Santiago, San Miguel, Chile
08

References and documents

Publications

  • Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4. PubMed 34130748 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02642757
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Dec 30, 2015
Start date
Dec 15, 2015
Primary completion
Jul 30, 2017
Completion
Jul 30, 2017
Last update
May 22, 2019

Study contacts

Nicolas Barticevic, MD
principal investigator · Instructor Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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