BiNational Quit Using Drugs Intervention Trial

NCT01942811 | Completed DMC

• 1 other identifier: BINAT 3P30DA027
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT) is a multi-site study conducted in the US (East Los Angeles) and Mexico (Tijuana) which aims to reduce drug demand on both sides of the border. The study also aims to build a collaborative partnership between the US and Mexico research teams. The Bi-National QUIT Study will conduct a randomized control trial for risky drug use in several Los Angeles area community health centers. The intent of the trial is to interrupt the progression to addiction for the casual and occasional users of illicit drugs and non-medical users of pharmaceuticals. The Bi-National QUIT protocol will include (1) a computerized assessment of the patient's drug-use history (2) very brief (\<5 minutes) clinician advice during a patients pre-arranged medical visit which will be preceded by a computerized assessment of the patient's drug-use history (3) a post visit assessment and video doctor (repeating the very brief clinician advice) in the waiting room (4) two post-visit telephone drug-use counseling sessions to be conducted by drug-health educators at approximately 2 and 6 weeks after the start of the intervention. Follow-up assessments will be conducted at 3 months post-randomization. Parallel activities will take place in the U.S./Los Angeles sites and Mexico/Tijuana sites. Data will be shared between both teams. Data analysis will be collaboratively conducted by both teams.

Conditions

Drug Use; Harmful Use

Keywords

DRUG PREVENTION; BINATIONAL; CASUAL USE OF ILLICIT DRUGS; BRIEF INTERVENTION; SBIRT

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Self-reported number of drug-free days at 3 months

  Past 30 and 90 days

Study Arms (2)

Intervention

EXPERIMENTAL

The Quit Using Drugs Intervention Trial (QUIT) experimental arm includes: screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.

Behavioral: Quit Using Drugs Intervention Trial

Control

NO INTERVENTION

Usual care and a health education booklet and video on cancer prevention

Interventions

Quit Using Drugs Intervention Trial BEHAVIORAL

The goal of the Quit Using Drugs Intervention Trial (QUIT) is to conduct a small RCT of a primary care clinic-based very brief intervention protocol for reducing the use of illegal drugs and the occurrences of drug-related harm in low-income, racially-diverse patient populations at two 'safety-net' clinics in Los Angeles. The design will emphasize screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.

Also known as: QUIT

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• Adult men and women 18 and older receiving care at the study clinics
• Will be living in the LA area for the next three months
• Have a phone number at which they can be reached for the next three months
• Has a primary care visit for themselves on the date of recruitment and enrollment
• Has a primary care visit with a regular clinic provider on the date of recruitment and enrollment
• English or Spanish-speaking
• Report of drug use in the previous 90 days (i.e., cocaine or amphetamines), and has an ASSIST score between 4 and 26 indicating 'at risk' drug use
• Accessible by telephone where they can be contacted over time during the study (to conduct follow-up health education phone calls)
• Able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including 2 telephone counseling sessions and 2-week, 6-week, and 3-month follow-up assessments
• Planning to be in the Los Angeles area for the next 3 months so they can complete the study period
• Clinicians • Regular staff primary care clinicians of our study clinics
• Patients
• Adult men and women 18 and older receiving care at the study clinics
• Will be living in the Tijuana area for the next three months

You may not qualify if:

• Patients
• Repeaters. Patients who have been screened or enrolled before will be asked a set of repeater questions. This includes a question on whether they have ever been involved in our UCLA study at the clinic before. We will also ask them a set of questions that combines aspects about the potential subject (mother's first name, father's first name, month and day of birth) that will screen them out if they screen again in the future.
• ASSIST Score: Drug Dependence. The RA will receive a message that the subject scored 27+ on all illicit drugs on the WHO ASSIST (i.e. indication of possible substance dependence/addiction). The RA will inform the patient that they are at risk for certain health behaviors and ask the patient if they want to disclose this information to their doctor. If they agree to disclose information to their doctor then we will fill out a letter informing the doctor of patient's dependence on specific drugs. We will also provide the patient with a list of local substance abuse treatment referrals. Please see Appendix A for copies of these referrals (Appendix A. Los Angeles County Substance Abuse Treatment Facilities).
• From Date of Screening Subject Enrolled in a Drug Treatment Facility. Subjects enrolled in a treatment program are excluded from the study. These subjects show commitment to the treatment program. Moreover, these program would serve as a competing intervention to ours, biasing the potential effect of our intervention.
• Patients
• Repeaters. Patients who have been screened or enrolled before will be asked a set of repeater questions. This includes a question on whether they have ever been involved in the Living Well study at the clinic before. We will also ask them a set of questions that combines aspects about the potential subject (mother's first name, father's first name, month and day of birth) that will screen them out if they screen again in the future.
• ASSIST Score: Drug Dependence. The RA will receive a message that the subject scored 27+ on all illicit drugs on the WHO ASSIST (i.e. indication of possible substance dependence/addiction). The RA will inform the patient that they are at risk for certain health behaviors and ask the patient if they want to disclose this information to their doctor. If they agree to disclose information to their doctor then we will fill out a letter informing the doctor of patient's dependence on specific drugs. We will also provide the patient with a list of local substance abuse treatment referrals.
• From Date of Screening Subject Enrolled in a Drug Treatment Facility. Subjects enrolled in a treatment program are excluded from the study. These subjects show commitment to the treatment program. Moreover, these program would serve as a competing intervention to ours, biasing the potential effect of our intervention.
• Clinicians

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: collaborator

Related Publications (1)

• Gelberg L, Andersen RM, Rico MW, Vahidi M, Natera Rey G, Shoptaw S, Leake BD, Serota M, Singleton K, Baumeister SE. A pilot replication of QUIT, a randomized controlled trial of a brief intervention for reducing risky drug use, among Latino primary care patients. Drug Alcohol Depend. 2017 Oct 1;179:433-440. doi: 10.1016/j.drugalcdep.2017.04.022. Epub 2017 Jun 13.

  PMID: 28844733 DERIVED

Study Officials

• Lillian Gelberg, MD, MSPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 16, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01