NCT01942876

Brief Summary

The proposed study will address the critical need to reduce illegal drug use, in particular drug use, and the occurrence of drug-related harm in low-income racially diverse patient populations at urban primary care safety-net clinics. Since they are at risk for accelerated trajectories to drug dependence once drug use begins, low-income racially diverse populations pose particular concern for public health policy makers and drug-use prevention efforts. The study will be the first to standardize drug screening and primary-care clinician delivered brief intervention among racially diverse "at risk" drug users, that is users with casual or frequent use without the physiological or psychological manifestations of dependence, to reduce their 'at risk' use of drugs, and it may effectively interrupt their pathway to dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

September 6, 2013

Last Update Submit

November 16, 2016

Conditions

Keywords

Drugsat riskcommunity health center patients

Outcome Measures

Primary Outcomes (1)

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

    past 30 and 90 days

Secondary Outcomes (1)

  • Decrease in drug-related harm (e.g., unemployment and job absenteeism, poor social support, poor health-related quality of life, HIV risk behaviors, motor vehicle accidents, and inpatient health services utilization).

    6 and 12 months post randomization

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

SHAM COMPARATOR

This arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.

Behavioral: Health behavior maintenance

Interventions

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

This attention-control arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.

Also known as: Attention-Control condition
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18 and older
  • report of drug use in the previous 90 days (i.e., (marijuana, crack/cocaine, amphetamines/methamphetamines, inhalants, sedatives or sleeping pills, hallucinogens, and opiates)
  • an ASSIST score between 4 and 26 indicating 'at risk' drug use
  • English or Spanish speaking
  • able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including 2 telephone counseling sessions and 3 month follow-up assessments

You may not qualify if:

  • Pregnant
  • Drug or alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

Related Publications (3)

  • Gelberg L, Andersen RM, Afifi AA, Leake BD, Arangua L, Vahidi M, Singleton K, Yacenda-Murphy J, Shoptaw S, Fleming MF, Baumeister SE. Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use. Addiction. 2015 Nov;110(11):1777-90. doi: 10.1111/add.12993.

  • Baumeister SE, Gelberg L, Leake BD, Yacenda-Murphy J, Vahidi M, Andersen RM. Effect of a primary care based brief intervention trial among risky drug users on health-related quality of life. Drug Alcohol Depend. 2014 Sep 1;142:254-61. doi: 10.1016/j.drugalcdep.2014.06.034. Epub 2014 Jul 4.

  • Bone CW, Goodfellow AM, Vahidi M, Gelberg L. Prevalence of Sexual Violence and its Association with Depression among Male and Female Patients with Risky Drug Use in Urban Federally Qualified Health Centers. J Urban Health. 2018 Feb;95(1):111-115. doi: 10.1007/s11524-017-0213-7.

Study Officials

  • Lillian Gelberg, MD, MSPH

    UCLA Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 16, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations