Opiate detoxification study

ISRCTN	ISRCTN14951861
DOI	https://doi.org/10.1186/ISRCTN14951861
Protocol serial number	N0120148502
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Leeds Mental Health Teaching NHS Trust (UK) NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 06/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Duncan Raistrick
Scientific

Addictions Unit
19 Springfield Mount
Woodhouse
Leeds
LS2 9NG
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To investigate whether buprenorphine opiate detoxification regime can be considered to be at least as clinically effective as a lofexidine regime, which was taken at the reference treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Drug addiction
Intervention	The study was a randomised controlled trial (RCT) using a non-inferiority approach. Non-inferiority is demonstrated if, within a 95% confidence interval, buprenorphine performs within a preset tolerance limit of clinically acceptable differences in outcomes, completion rates between the two treatments. Individual ready for heroin detoxification were given information about the trial and invited to participate. Consenting participants were then randomised to one of the two treatments. Detoxification was undertaken in a specialist outpatient clinic according to pre-defined protocols. The detoxification procedure required that this was an open label trial. The primary outcome was whether or not an individual completed the detoxification. Completion of the planned detoxification was taken to be an objective marker of both the acceptability of the pharmacotherapy and also the effectiveness of the detoxification procedure in the clinic. Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure. The difference in completion proportions between the two treatments was then tested to determine whether or not the treatments could be considered clinically equivalent. Data were also collected for individuals who declined randomisation and instead chose their treatment. Additional secondary outcome measures were substance use, dependence, psychological health, social satisfaction and treatment satisfaction.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Buprenorphine, lofexidine
Primary outcome measure(s)	The primary outcome was whether or not an individual completed the detoxification.
Key secondary outcome measure(s)	Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure.
Completion date	30/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Key inclusion criteria	Individual ready for heroin detoxification who agreed to take part in the trial.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2000
Date of final enrolment	30/09/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addictions Unit

Leeds
LS2 9NG
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2005		Yes	No