Alcohol-Related DisordersPhase 3NCT01573416
"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."
A Phase 3 study testing ASSIST-linked brief intervention for hazardous and harmful substance use. and Observation in people with Alcohol-Related Disorders and Substance-Related Disorders, run by Pontificia Universidad Catolica de Chile at 30 sites in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders, Substance-Related Disorders, Substance Abuse
- What is being tested?
- ASSIST-linked brief intervention for hazardous and harmful substance use. and Observation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 30 sitesChile
- Study dates
- Dec 2011to Apr 2013
- Phase
- Phase 3
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Pregnant women.
- Users with cognitive disabilities.
- Users with language and communication disabilities.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Chile30 sites
5ta. Comisaría Conchalí
Conchalí, RM
CS Alberto Bachelet
Conchalí, RM
CS José Symon Ojeda
Conchalí, RM
CS Juanita Aguirre
Conchalí, RM
CS Lucas Sierra
Conchalí, RM
SAPU Lucas Sierra
Conchalí, RM
CESFAM Dr. Sergio Aguilar
Coquimbo, IV
CESFAM San Juan
Coquimbo, IV
CESFAM Santa Cecilia
Coquimbo, IV
CESFAM Tierras Blancas
Coquimbo, IV
SAPU Dr. Sergio Aguilar
Coquimbo, IV
SAPU Tierras Blancas
Coquimbo, IV
43va. Comisaría Peñalolén
Peñalolén, RM
CESFAM Lo Hermida
Peñalolén, RM
CESFAM Padre Gerardo Whelan
Peñalolén, RM
CS Carol Urzúa Ibañez
Peñalolén, RM
CS La Faena
Peñalolén, RM
SAPU Lo Hermida
Peñalolén, RM
26va. Comisaría Pudahuel
Pudahuel, RM
CESFAM Gustavo Molina
Pudahuel, RM
CESFAM RAúl Silva Henríquez
Pudahuel, RM
CESFAM Violeta Parra
Pudahuel, RM
Consultorio Estrella
Pudahuel, RM
SAPU La Estrella
Pudahuel, RM
14va. Comisaría San Bernardo
San Bernardo, RM
APS Carol Urzúa
San Bernardo, RM
APS Confraternidad
San Bernardo, RM
APS El Manzano
San Bernardo, RM
APS Raúl Cuevas
San Bernardo, RM
SAPU Raúl Brañes
San Bernardo, RM
About this study
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.
Read more
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.
- Being tested
- ASSIST-linked brief intervention for hazardous and harmful substance use., Observation
- Keywords
- Alcohol, Abuse, Drugs, Brief intervention, ASSIST
- Medical subject headings
- Alcohol-Related Disorders, Substance-Related Disorders, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIST-linked brief intervention for hazardous and harmful substance use.Other
ASSIST-linked brief intervention will be applied to users achieving moderate risk scores in the ASSIST questionnaire. If after randomization are selected to enter the intervention group, they will receive a ten minute counseling carried immediately after the screening instrument. This intervention group will be re-evaluated after 3 months with the same ASSIST screening instrument.
ObservationOther
Subjects who obtain a moderate risk score in the ASSIST screening questionnaire and after randomization are selected for the control group, will receive a brochure with substance-abuse information without any further conversation about the subject with the caregiver. This observation group will be re-evaluated after 3 months with the same ASSIST screening instrument.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Other: Observation |
| Intervention group | Active comparator | Not described Receives: Other: ASSIST-linked brief intervention for hazardous and harmful substance use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention ASSIST screening score.
3 months after being recruited, users with moderate risk in the ASSIST questionnaire who received either a brief intervention or observation will be re-evaluated with the same ASSIST instrument. In both the intervened and the control group, changes in the post-intervention ASSIST score will be measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
- Responsible party
- Principal investigator, Fernando Poblete Arrué, Pontificia Universidad Catolica de Chile
- Investigators
- Fernando Poblete, MD, MPH, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573416
- Sponsor's protocol ID
- CEDAUC-11-205
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2012
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.
PubMed 22126102Beich A, Thorsen T, Rollnick S. Screening in brief intervention trials targeting excessive drinkers in general practice: systematic review and meta-analysis. BMJ. 2003 Sep 6;327(7414):536-42. doi: 10.1136/bmj.327.7414.536.
PubMed 12958114Ballesteros J, Duffy JC, Querejeta I, Arino J, Gonzalez-Pinto A. Efficacy of brief interventions for hazardous drinkers in primary care: systematic review and meta-analyses. Alcohol Clin Exp Res. 2004 Apr;28(4):608-18. doi: 10.1097/01.alc.0000122106.84718.67.
PubMed 15100612Hungerford DW, Pollock DA, Todd KH. Acceptability of emergency department-based screening and brief intervention for alcohol problems. Acad Emerg Med. 2000 Dec;7(12):1383-92. doi: 10.1111/j.1553-2712.2000.tb00496.x.
PubMed 11099429Anderson PA, Grey SF, Nichols C, Parran TV Jr, Graham AV. Is screening and brief advice for problem drinkers by clergy feasible? A survey of clergy. J Drug Educ. 2004;34(1):33-40. doi: 10.2190/3QH2-VLWN-ELWM-KC67.
PubMed 15468746Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
PubMed 18077300Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
PubMed 10522717Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.
PubMed 16355071WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
PubMed 12199834Whitlock EP, Polen MR, Green CA, Orleans T, Klein J; U.S. Preventive Services Task Force. Behavioral counseling interventions in primary care to reduce risky/harmful alcohol use by adults: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2004 Apr 6;140(7):557-68. doi: 10.7326/0003-4819-140-7-200404060-00017.
PubMed 15068985Hawks D. Broadening the base of treatment for alcohol problems: a report which deserves to be debated. The limits of treatment and importance of prevention. Br J Addict. 1991 Jul;86(7):848-9. doi: 10.1111/j.1360-0443.1991.tb01836.x. No abstract available.
PubMed 1912733Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
PubMed 37158538
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT01573416
- Acronym / sponsor ID
- CEDAUC-11-205
- Keywords
- Alcohol, Abuse, Drugs, Brief intervention, ASSIST
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Apr 2012 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Observation |
| Intervention group | Active comparator | Other: ASSIST-linked brief intervention for hazardous and harmful substance use. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Pregnant women.
- Users with cognitive disabilities.
- Users with language and communication disabilities.
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 |
|---|---|---|
| ASSIST-linked brief intervention for hazardous and harmful substance use.ASSIST-linked brief intervention will be applied to users achieving moderate risk scores in the ASSIST questionnaire. If after randomization are selected to enter the intervention group, they will receive a ten minute counseling carried immediately after the screening instrument. This intervention group will be re-evaluated after 3 months with the same ASSIST screening instrument. | Other | Intervention group |
| ObservationSubjects who obtain a moderate risk score in the ASSIST screening questionnaire and after randomization are selected for the control group, will receive a brochure with substance-abuse information without any further conversation about the subject with the caregiver. This observation group will be re-evaluated after 3 months with the same ASSIST screening instrument. | Other | Control group |
Primary outcome
Post-intervention ASSIST screening score.
Time frame: 3 months
3 months after being recruited, users with moderate risk in the ASSIST questionnaire who received either a brief intervention or observation will be re-evaluated with the same ASSIST instrument. In both the intervened and the control group, changes in the post-intervention ASSIST score will be measured.
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 9 Oct 2013.
- Background: PubMed 22126102Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.
- Background: PubMed 12958114Beich A, Thorsen T, Rollnick S. Screening in brief intervention trials targeting excessive drinkers in general practice: systematic review and meta-analysis. BMJ. 2003 Sep 6;327(7414):536-42. doi: 10.1136/bmj.327.7414.536.
- Background: PubMed 15100612Ballesteros J, Duffy JC, Querejeta I, Arino J, Gonzalez-Pinto A. Efficacy of brief interventions for hazardous drinkers in primary care: systematic review and meta-analyses. Alcohol Clin Exp Res. 2004 Apr;28(4):608-18. doi: 10.1097/01.alc.0000122106.84718.67.
- Background: PubMed 11099429Hungerford DW, Pollock DA, Todd KH. Acceptability of emergency department-based screening and brief intervention for alcohol problems. Acad Emerg Med. 2000 Dec;7(12):1383-92. doi: 10.1111/j.1553-2712.2000.tb00496.x.
- Background: PubMed 15468746Anderson PA, Grey SF, Nichols C, Parran TV Jr, Graham AV. Is screening and brief advice for problem drinkers by clergy feasible? A survey of clergy. J Drug Educ. 2004;34(1):33-40. doi: 10.2190/3QH2-VLWN-ELWM-KC67.
- Background: PubMed 18077300Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
- Background: PubMed 10522717Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
- Background: PubMed 16355071Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.
- Background: PubMed 12199834WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
- Background: PubMed 15068985Whitlock EP, Polen MR, Green CA, Orleans T, Klein J; U.S. Preventive Services Task Force. Behavioral counseling interventions in primary care to reduce risky/harmful alcohol use by adults: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2004 Apr 6;140(7):557-68. doi: 10.7326/0003-4819-140-7-200404060-00017.
- Background: PubMed 1912733Hawks D. Broadening the base of treatment for alcohol problems: a report which deserves to be debated. The limits of treatment and importance of prevention. Br J Addict. 1991 Jul;86(7):848-9. doi: 10.1111/j.1360-0443.1991.tb01836.x. No abstract available.
- Derived from this study: PubMed 37158538Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
- Pontificia Universidad Católica de Chile, School of MedicineLink provided by the sponsor.
- Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)Link provided by the sponsor.
- Family Medicine Dept., Pontificia Universidad Católica de Chile, School of Medicine.Link provided by the sponsor.
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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.
Fernando Poblete, MD, MPH study director
Pontificia Universidad Catolica de Chile
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASSIST-linked brief intervention for hazardous and harmful substance use. and Observation in people with Alcohol-Related Disorders and Substance-Related Disorders, run by Pontificia Universidad Catolica de Chile at 30 sites in Chile.
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 3 inclusion and 3 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-intervention ASSIST screening score. (time frame: 3 months). 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 NCT01573416, which also lists 12 linked publications.
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 9 Oct 2013.