Phase III project, randomised controlled trial of brief intervention for illicit drugs linked to the World Health Organization (WHO) alcohol, smoking and substance involvement screening test (ASSIST): multicentre study conducted in Australia, Brazil, India, Spain, Thailand and USA

ISRCTN	ISRCTN39055704
DOI	https://doi.org/10.1186/ISRCTN39055704
Protocol serial number	RPC024
Sponsor	World Health Organization (WHO)/The Department of Mental Health and Substance Abuse (MSD) (Switzerland)
Funder	World Health Organization (WHO)/The Department of Mental Health and Substance Abuse (MSD) (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Vladimir Poznyak
Scientific

World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	poznyak@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ASSIST
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Substance abuse
Intervention	1. Both groups: ASSIST and a demographic profile questionnaire 2. Intervention group: brief intervention for the drug scoring highest on ASSIST and related self-help materials 3. Control group: on waitlist and brief intervention at 3 months follow-up
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	1047
Key inclusion criteria	1. Age 18 - 50 years 2. Member of main ethnic group in the population 3. Able to communicate in the national language 4. Willing for three month follow-up 5. Be able to be followed up three months later and give contact details of two to three other people 6. Have a fixed address and provide contact details of their home
Key exclusion criteria	1. Any pending court session with possible incarceration within three months 2. Any severe intellectual disability or cognitive impairment 3. Severe behaviour disturbance or psychotic symptoms 4. Tendencies to violent or aggressive behaviour 5. Intoxicated or withdrawal from alcohol or drugs 6. Incarcerated or in the environment with no free movements in the last three months
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2005

World Health Organization (WHO)

Geneva-27
CH-1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008		Yes	No