Clinical trial NCT01573416: "Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."
Official title: "Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol-Related Disorders
Substance-Related Disorders
Substance Abuse
Keywords: Alcohol
Abuse
Drugs
Brief intervention
ASSIST
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
First posted: 2012-04-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Alcohol and drugs consumption are among the highest risk factor for health in Chile and abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden of disease while lost years of healthy life are higher than many other risk factors such as hypertension, overweight and obesity, and hyperglycemia. It is important to say that the impact of alcohol consumption is greater in younger age groups where fatal injuries occur relatively early in life, as well.

In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even greater in young adults and adolescents and is associated with other mental health issues and poorer life quality. Those who have consumed marihuana during the last year, 25% report dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers. This data reinforce the need to design and implement strategies for reducing alcohol and drugs consumption in our population.

Also, it is well known that a high number of those who suffers from any addiction problem do not get attention in a specialized center. The are many barriers to do so, such as lack of motivation, lack of resources, social problems, access to care problems, and so on.

Chile has a shortage of preventive interventions for those at risk to develop an addiction at an early stage of substance use because front line health services (Primary health care and emergency care) and other social services (police stations, local justice courts) do not have a screening system and a model of brief intervention.

The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC) and its Department of Family Medicine, is working in conjunction with SENDA (Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design, implement and evaluate a communal system for early detection, brief intervention and referral to treatment (SBIRT), in people older than 18 years, with substance consumption in five municipalities in the country.

The aid of this study is to demonstrate that a model of brief intervention is more effective than the approach currently used in patients with substance use at moderate risk (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a group to receive brief intervention and a control group that is kept in control and waiting list being re-evaluated three months later.

The target population is composed by users whose ASSIST screening scores place them in the moderate risk group, for which there has not been defined a structured intervention yet by our health system. The information will be obtained from the scores obtained after the application of the ASSIST-WHO questionnaire.


Eligibility criteria: Inclusion Criteria:

* Men and women older than 18 years and 50 years
* Achieving a moderate risk score in the ASSIST screening questionnaire.
* Without any similar intervention in the last 3 months. (ie. AUDIT test).

Exclusion Criteria:

* Pregnant women.
* Users with cognitive disabilities.
* Users with language and communication disabilities.

Primary outcomes:
measure: Post-intervention ASSIST screening score.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coquimbo
country: Chile
facility: CESFAM Dr. Sergio Aguilar
state: IV
city: Coquimbo
country: Chile
facility: CESFAM San Juan
state: IV
city: Coquimbo
country: Chile
facility: CESFAM Santa Cecilia
state: IV
city: Coquimbo
country: Chile
facility: CESFAM Tierras Blancas
state: IV
city: Coquimbo
country: Chile
facility: SAPU Dr. Sergio Aguilar
state: IV
city: Coquimbo
country: Chile
facility: SAPU Tierras Blancas
state: IV
city: Conchalí
country: Chile
facility: 5ta. Comisaría Conchalí
state: RM
city: Conchalí
country: Chile
facility: CS Alberto Bachelet
state: RM
city: Conchalí
country: Chile
facility: CS José Symon Ojeda
state: RM
city: Conchalí
country: Chile
facility: CS Juanita Aguirre
state: RM
city: Conchalí
country: Chile
facility: CS Lucas Sierra
state: RM
city: Conchalí
country: Chile
facility: SAPU Lucas Sierra
state: RM
city: Peñalolén
country: Chile
facility: 43va. Comisaría Peñalolén
state: RM
city: Peñalolén
country: Chile
facility: CESFAM Lo Hermida
state: RM
city: Peñalolén
country: Chile
facility: CESFAM Padre Gerardo Whelan
state: RM
city: Peñalolén
country: Chile
facility: CS Carol Urzúa Ibañez
state: RM
city: Peñalolén
country: Chile
facility: CS La Faena
state: RM
city: Peñalolén
country: Chile
facility: SAPU Lo Hermida
state: RM
city: Pudahuel
country: Chile
facility: 26va. Comisaría Pudahuel
state: RM
city: Pudahuel
country: Chile
facility: CESFAM Gustavo Molina
state: RM
city: Pudahuel
country: Chile
facility: CESFAM RAúl Silva Henríquez
state: RM
city: Pudahuel
country: Chile
facility: CESFAM Violeta Parra
state: RM
city: Pudahuel
country: Chile
facility: Consultorio Estrella
state: RM
city: Pudahuel
country: Chile
facility: SAPU La Estrella
state: RM
city: San Bernardo
country: Chile
facility: 14va. Comisaría San Bernardo
state: RM
city: San Bernardo
country: Chile
facility: APS Carol Urzúa
state: RM
city: San Bernardo
country: Chile
facility: APS Confraternidad
state: RM
city: San Bernardo
country: Chile
facility: APS El Manzano
state: RM
city: San Bernardo
country: Chile
facility: APS Raúl Cuevas
state: RM
city: San Bernardo
country: Chile
facility: SAPU Raúl Brañes
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Fernando Poblete, MD, MPH
role: STUDY_DIRECTOR
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