Drug UseBiN-QUITNCT01942811
BiNational Quit Using Drugs Intervention Trial
A study testing Quit Using Drugs Intervention Trial in people with Drug Use and Harmful Use, run by University of California, Los Angeles.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Use, Harmful Use
- What is being tested?
- Quit Using Drugs Intervention Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US Sites: Inclusion Criteria
- 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
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- 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
- Mexico Sites: Inclusion Criteria
- 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
- 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
- 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 Tijuana area for the next 3 months so they can complete the study period
- Clinicians
- Regular staff primary care clinicians of our study clinics
Who cannot join
- US Sites: Exclusion Criteria
- Patients
- Pregnancy. Women who report being pregnant at the time of randomization will be excluded from participation. This latter exclusion criterion is based on the following reasons: (a) The interaction of drug use (in any amount) and fetal-maternal health is physiologically complex and beyond the scope of this proposed intervention. (b) Drug users who are pregnant are considered high-risk pregnancies and will likely be lost to follow-up during the study as they will be promptly referred by their primary care clinician to an obstetrician per usual clinic protocol. However, enrolled patients who become pregnant after the intervention will not be withdrawn. Their eventual exits from the study will be counted as drop-outs and will be included as "no change" in our "intent to treat" analysis. Finally, (c) a tailored brief intervention protocol for pregnant women may require more than simple clinician advice and a 2-session phone health education program. Such an intervention would be more effective if designed around the activities of prenatal care. Previous RCTs of problem alcohol use targeting healthy adults have excluded patients who are pregnant.8,9
- Homeless status. The clinics we have chosen have large numbers of homeless patients. Since this is a study on the general poverty population, we are asking homeless status in order to avoid over-sampling homeless patients. We will set a quota on number of homeless patients we can enroll without over-sampling these patients. If we reach this quota, we will apply homeless status as an exclusion criteria for subsequent subjects.
- 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).
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- 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 • No exclusion criteria apply to clinicians
- Mexico Sites: Exclusion Criteria
- Patients
- Pregnancy. Women who report being pregnant at the time of randomization will be excluded from participation. This latter exclusion criterion is based on the following reasons: (a) The interaction of drug use (in any amount) and fetal-maternal health is physiologically complex and beyond the scope of this proposed intervention. (b) Drug users who are pregnant are considered high-risk pregnancies and will likely be lost to follow-up during the study as they will be promptly referred by their primary care clinician to an obstetrician per usual clinic protocol. However, enrolled patients who become pregnant after the intervention will not be withdrawn. Their eventual exits from the study will be counted as drop-outs and will be included as "no change" in our "intent to treat" analysis. Finally, (c) a tailored brief intervention protocol for pregnant women may require more than simple clinician advice and a 2-session phone health education program. Such an intervention would be more effective if designed around the activities of prenatal care. Previous RCTs of problem alcohol use targeting healthy adults have excluded patients who are pregnant.
- Homeless status. The clinics we have chosen have large numbers of homeless patients. Since this is a study on the general poverty population, we are asking homeless status in order to avoid over-sampling homeless patients. We will set a quota on number of homeless patients we can enroll without over-sampling these patients. If we reach this quota, we will apply homeless status as an exclusion criteria for subsequent subjects.
- 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
- No exclusion criteria apply to clinicians
About this study
Official title: US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT)
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
- Being tested
- Quit Using Drugs Intervention Trial
- Keywords
- DRUG PREVENTION, BINATIONAL, CASUAL USE OF ILLICIT DRUGS, BRIEF INTERVENTION, SBIRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Using Drugs Intervention TrialBehavioural
Also called QUIT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Quit Using Drugs Intervention Trial |
| Control | No intervention | Usual care and a health education booklet and video on cancer prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Self-reported number of drug-free days at 3 months
Measured: Past 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Responsible party
- Principal investigator, Lillian Gelberg, University of California, Los Angeles
- Investigators
- Lillian Gelberg, MD, MSPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942811
- Sponsor's protocol ID
- BINAT 3P30DA027
- Acronym
- BiN-QUIT
- Status last verified
- Jan 2015
- First submitted
- 6 Sep 2013
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28844733
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT)
- ClinicalTrials.gov ID
- NCT01942811
- Acronym / sponsor ID
- BiN-QUIT / BINAT 3P30DA027
- Conditions
- Drug Use, Harmful Use
- Keywords
- DRUG PREVENTION, BINATIONAL, CASUAL USE OF ILLICIT DRUGS, BRIEF INTERVENTION, SBIRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Quit Using Drugs Intervention TrialThe 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. |
| Control | No intervention | –Usual care and a health education booklet and video on cancer prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- US Sites: Inclusion Criteria
- 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
Key exclusion criteria (17 listed)
- US Sites: Exclusion Criteria
- Patients
- Pregnancy. Women who report being pregnant at the time of randomization will be excluded from participation. This latter exclusion criterion is based on the following reasons: (a) The interaction of drug use (in any amount) and fetal-maternal health is physiologically complex and beyond the scope of this proposed intervention. (b) Drug users who are pregnant are considered high-risk pregnancies and will likely be lost to follow-up during the study as they will be promptly referred by their primary care clinician to an obstetrician per usual clinic protocol. However, enrolled patients who become pregnant after the intervention will not be withdrawn. Their eventual exits from the study will be counted as drop-outs and will be included as "no change" in our "intent to treat" analysis. Finally, (c) a tailored brief intervention protocol for pregnant women may require more than simple clinician advice and a 2-session phone health education program. Such an intervention would be more effective if designed around the activities of prenatal care. Previous RCTs of problem alcohol use targeting healthy adults have excluded patients who are pregnant.8,9
- Homeless status. The clinics we have chosen have large numbers of homeless patients. Since this is a study on the general poverty population, we are asking homeless status in order to avoid over-sampling homeless patients. We will set a quota on number of homeless patients we can enroll without over-sampling these patients. If we reach this quota, we will apply homeless status as an exclusion criteria for subsequent subjects.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quit Using Drugs Intervention TrialAlso: QUITThe 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. | Behavioural | Intervention |
Primary outcome
Change from Baseline Self-reported number of drug-free days at 3 months
Time frame: Past 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Derived from this study: PubMed 28844733Gelberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Gelberg, MD, MSPH principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Quit Using Drugs Intervention Trial in people with Drug Use and Harmful Use, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Self-reported number of drug-free days at 3 months (time frame: Past 30 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.