RECRUITING

Multi-Component Breath Alcohol Intervention Phase 3

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Official Title

Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3

Quick Facts

Study Start:2025-05-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06994962

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.

Ages Eligible for Study:18 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be between the ages of 18-25
  2. * Be able to read English and complete study evaluations
  3. * At least occasional heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) over the prior 30 days
  4. * Frequent consumption of at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.
  1. * Severe substance use disorder
  2. * Be psychotic or otherwise severely psychiatrically disabled
  3. * Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

Contacts and Locations

Study Contact

Jade Martinez, B.S.
CONTACT
(617) 373-5132
ja.martinez@northeastern.edu
Allie Farone, M.S.
CONTACT
a.farone@northeastern.edu

Principal Investigator

Robert F Leeman, Ph.D.
PRINCIPAL_INVESTIGATOR
Northeastern University

Study Locations (Sites)

Northeastern University
Boston, Massachusetts, 02115-5005
United States

Collaborators and Investigators

Sponsor: Northeastern University

  • Robert F Leeman, Ph.D., PRINCIPAL_INVESTIGATOR, Northeastern University

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 Registration Dates

Study Start Date2025-05-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use
  • Alcohol Drinking
  • Drinking Behavior