Preventing Drug Use in Low Income Clinic Populations (QUIT)
16 novembre 2016 mis à jour par: University of California, Los Angeles
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The Quit Using Drugs Intervention Trial (QUIT) will be the first randomized controlled trial in the U.S. that is powered to detect the effect of a primary care clinician delivered brief intervention protocol for reducing 'at risk' drug use and drug-related harm among low-income adult patients (ages 18 and older) at multiple safety net clinics in Los Angeles County.
For this small trial, we will sample patients with 'at risk' use of drugs (marijuana, crack/cocaine, amphetamines/methamphetamines, inhalants, sedatives or sleeping pills, hallucinogens, and opiates), the most commonly used serious drugs among patients at our clinic sites.
"At risk" drug use is defined in this study as current use (past 90 days) of drug measured as a self-reported total score of 4 to 26 on the WHO Alcohol Substance Involvement Screening Test (ASSIST).
A total of 7,000-8,000 patients will be approached for screening to yield a 3-month effective sample size of 245 eligible patients per condition (1) an intervention condition involving drug use health education or (2) a control condition involving care as usual.
In the intervention condition, very brief (less than 5 minutes) clinician advice regarding quitting drug use will be followed by two 2 and 6 week post-visit drug health education sessions on quitting drug use and cautioning against use of other 'at risk' substance use such as alcohol and tobacco.
Patients assigned to the control condition will receive standard care for drug use at the baseline visit with their clinician.
Follow-up assessments will be conducted at 3 month post-randomization.
The framework for the QUIT project is the Social Action Theory, and the brief intervention protocol is based on NIDA's principles on prevention research and the utility of the 5 A's approach for assisting behavioral changes among patients (Ask, Advise, Assess, Assist, Arrange) in the clinic setting.
If found to be effective in the community health center setting, this clinician and telephone drug-use health education program could become a model for health promotion activities.
that would be expanded to all 'at risk' substance use and shared between community health centers.
Type d'étude
Interventionnel
Inscription (Réel)
411
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90024
- UCLA
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant
- Drug or alcohol dependence
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention
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.
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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.
Autres noms:
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Comparateur factice: Control
This arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.
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This attention-control arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change from Baseline of Self-reported number of drug-free days at 3 month
Délai: past 30 and 90 days
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past 30 and 90 days
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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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).
Délai: 6 and 12 months post randomization
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6 and 12 months post randomization
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Lillian Gelberg, MD, MSPH, UCLA Department of Family Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2011
Achèvement primaire (Réel)
1 février 2013
Achèvement de l'étude (Réel)
1 février 2013
Dates d'inscription aux études
Première soumission
6 septembre 2013
Première soumission répondant aux critères de contrôle qualité
10 septembre 2013
Première publication (Estimation)
16 septembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
18 novembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- DESPR DA022445
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