Condition category
Mental and Behavioural Disorders
Date applied
13/02/2008
Date assigned
26/02/2008
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Marsden

ORCID ID

Contact details

Institute of Psychiatry
King's College London
PO Box 048
4 Windsor Walk
London
SE5 8AF
United Kingdom
-
J.Marsden@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V#1, 10/01/06

Study information

Scientific title

An evaluation of a brief assessment-led intervention with young non-injecting drug users

Acronym

Study hypothesis

That participants receiving a brief assessment-led intervention would at 3 months follow-up have a lower mean frequency of cannabis use, cocaine use, crack cocaine use and MDMA (3,4 methylenedioxymethamphetamine; Ecstasy) use combined than delayed assessment control participants

Ethics approval

King's College London. Date of approval: 17/10/2005 (ref: 05/Q0706/219)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Substance misuse

Intervention

Experimental: A brief assessment-led intervention
a. Drugs and Lifestyle Assessment
b. Manual guided 30 minute feedback interview
Control 1: Assessment only
Control 2: Delayed assessment

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Combined frequency of cocaine powder use, crack cocaine use, MDMA use and cannabis use, assessed at baseline and 90 days.

Secondary outcome measures

The following were assessed at baseline and 90 days:
1. Typical intensity of cannabis use, cocaine use, crack cocaine use and MDMA use at 90 days
2. Drug dependency: Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) Personality Disorders (Structured Clinical Interview for DSM-IV Axis II Personality Disorders; SCID-II)
3. Alcohol frequency and intensity
4. Hazardous drinking: The Alcohol Use Disorders Identification Test (AUDIT)
5. General health: EQ-5D A multi-dimensional Quality of Health Instrument (EurQol)
6. Psychological health: General Health Questionnaire (GHQ 12)
7. Engagement with health and social services

Overall trial start date

01/10/2005

Overall trial end date

29/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sixteen to 28 years old
2. Using either cannabis, cocaine powder, crack cocaine, or MDMA on four days in previous month
3. Able speak and comprehend English
4. Written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

255

Participant exclusion criteria

1. In contact with a drug/alcohol treatment agency in previous 12 months
2. Used opiates more than 30 days in the previous 90 days or in the previous 48 hours before interview
3. Injected more than once in the last 12 months and no more than ten times lifetime
4. Receiving specialist treatment for a mental health problem
5. Participated in a similar research study in the previous 12 months

Recruitment start date

01/10/2005

Recruitment end date

29/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
Kings College London
4 Windsor Walk
London
SE5 8AF
United Kingdom
-
gill.lambert@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Government

Funder name

Department of Health of England & Wales, Drug Misuse Research Initiative (Phase 2) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes