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Project RAD: A Brief Intervention for Young Adult Alcohol or Marijuana Users

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ClinicalTrials.gov Identifier: NCT03801096
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Marcel de Dios, PhD, University of Houston

Brief Summary:
This is a pilot study of the feasibility, acceptability, and effectiveness of a brief, one-session intervention for a diverse sample of 44 young adults who report alcohol binge drinking or marijuana use in the past month. The proposed study will utilize a two-group randomized controlled trial (RCT) design. Participants will be randomized to one of two interventions conditions: 1) Narrative-based Therapeutic Assessment (NbTa) or 2) Health Education (HE) control condition. Participants will be assessed on their 7- and 30-day alcohol and marijuana use at baseline and at 6 month follow-up.

Condition or disease Intervention/treatment Phase
Alcohol; Use, Problem Marijuana Usage Behavioral: Narrative Based Therapuetic Assessment (NbTa) Behavioral: Health Education Control Condition (HE) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-group randomized controlled trial (RCT) design
Masking: Single (Outcomes Assessor)
Masking Description: Research Assistant collecting data will be blinded to condition
Primary Purpose: Treatment
Official Title: Project RAD: A Brief Intervention for Young Adult Alcohol or Marijuana Users
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Narrative Based Therapuetic Assessment Behavioral: Narrative Based Therapuetic Assessment (NbTa)
The NbTa interventiom will guide participants through an exploration of their human experience through stories and narratives. The interventionist will facilitate a collaborative process by which participants will explore the unique themes and meanings of their personal narrative (Parry & Doan, 1994) with respect to alcohol and drug use. In addition, participants will also be guided towards considering the re-authorship of personal narratives. The techniques utilized in NbTa aim to dislodge problem saturated narratives and derive more complete personal narratives and meanings (White & Epston, 1990).

Active Comparator: Health Education (HE) Behavioral: Health Education Control Condition (HE)
The Health Education session is a didactic 45-minute session that focusses on three health-related topics: 1) Sleep, 2) Physical Activity, and 3) Nutrition. The goal of the session is to present health-related information to participants through videos and dydadic presentation.




Primary Outcome Measures :
  1. Weekly Alcohol Use Frequency at 6 month follow-up [ Time Frame: 6 months after baseline ]
    Self-reported days of alcohol use in the past 7 days captured and computed using the Timeline Follow Back (Sobel & Sobel, 1992).

  2. Monthly Alcohol Use Frequency at 6 month follow-up [ Time Frame: 6 months after baseline ]
    Self-reported days of alcohol use in the past 30 days captured and computed using the Timeline Follow Back (Sobel & Sobel, 1992).

  3. Weekly Marijuana Use Frequency at 6 month follow-up [ Time Frame: 6 months after baseline ]
    Self-reported days of marijuana use in the past 7 days captured and computed using the Timeline Follow Back (Sobel & Sobel, 1992) and confirmed with Urine drug screening tests.

  4. Monthly Marijuana Use Frequency at 6 month follow-up [ Time Frame: 6 months after baseline ]
    Self-reported days of marijuana use in the past 30 days captured and computed using the Timeline Follow Back (Sobel & Sobel, 1992) and confirmed with Urine drug screening tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All self-represented gender identities will be included.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 25.
  • Able to speak and read the English language.
  • Agree to participate in the study and be available for two study visits that will occur at baseline and approximately 6-month after the baseline visit.
  • Report at least 1 alcohol binge drinking episode in the past month (binge drinking is defined as 4 or more drinks in a 2 hour period for women, 5 or more drinks in a 2 hour period for men (NIAAA, 2004) OR report the use of marijuana on at least 1 occasion in the past month.
  • Have access to an email account or phone number to communicate with study personnel.
  • Identify as a member of a minority group, disadvantaged group, or marginalized based on race, ethnicity, heritage, immigration status, gender, sexual orientation, religion, and disability status.

Exclusion Criteria:

  • In the past month, consumed an average of 7 or more drinks per week for females or 14 or more drinks per week for males.
  • Marijuana use on 4 or more days per week in the past month.
  • A pattern of impaired functioning due to alcohol or marijuana use during the past month;
  • In the past year, family members, close friends, or medical providers have expressed concerns about their alcohol or marijuana use and have advised them to quit.
  • A history of a Substance Use Disorders (Alcohol; Amphetamines; Cannabis; Cocaine; Hallucinogens; Opioids; Phencyclidine; and Sedatives, Hypnotics and Anxiolytics).
  • A history of a chronic and/or severe psychiatric disorder that would interfere with participation (i.e., Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Bipolar Disorder, or a Mood Disorder with Psychotic Features).
  • Unavailable for a 2.5 hour baseline visit and a follow-up visit 6 months post baseline.
  • Unable to provide contact information to allow for study related communication.
  • Pregnant or nursing.
  • Identified as a UH student that the PI (Dr. Marcel de Dios) has had or will likely have direct access to or influence over through academic activities such as coursework, advising, or research mentoring.
  • Identified by the study PI as unsuitable for participating in the study due to significant circumstances that would interfere with participation including threatening behavior or an inability/unwillingness to respond to basic study related questions and instructions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801096


Contacts
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Contact: Marcel de Dios 7137436687 madedios@central.uh.edu
Contact: Lycinda Rodriguez, MS 7137436686 lrodriguez1@loyola.edu

Sponsors and Collaborators
University of Houston

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Responsible Party: Marcel de Dios, PhD, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03801096     History of Changes
Other Study ID Numbers: 00001218
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs