Condition category
Mental and Behavioural Disorders
Date applied
08/03/2005
Date assigned
20/04/2005
Last edited
18/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.show.scot.nhs.uk/CSO/Publications/ExecSumms/JanFeb05/9.8%20Robertson.pdf

Contact information

Type

Scientific

Primary contact

Dr Roy Robertson

ORCID ID

Contact details

Muirhouse Medical Group
1 Muirhouse Avenue
Edinburgh
EH4 4PL
United Kingdom
+44 (0)131 537 4343
Roy.Robertson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

K/OPR/2/2/D399

Study information

Scientific title

Acronym

Study hypothesis

To determine the efficacy of dihdrocodeine compared to methadone in the treatment of opiate dependence.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Opiate dependence

Intervention

Substitute treatment with methadone or dihydrocodeine.

Intervention type

Drug

Phase

Not Specified

Drug names

Dihydrocodeine (DHC), methadone

Primary outcome measures

1. Survival
2. Retention in treatment
3. Continued drug use (particularly injecting)
4. Criminal behaviour

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Opiate dependent patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2000

Recruitment end date

01/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Muirhouse Medical Group
Edinburgh
EH4 4PL
United Kingdom

Sponsor information

Organisation

Chief Scientist Office (UK) - Scottish Executive Health Department

Sponsor details

St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom
+44 (0)131 244 2077
Peter.craig@scotland.gsi.gov.uk

Sponsor type

Government

Website

http://www.sehd.scot.nhs.uk/cso/

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) - Scottish Executive Health Department

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17156174

Publication citations

  1. Results

    Robertson JR, Raab GM, Bruce M, McKenzie JS, Storkey HR, Salter A, Addressing the efficacy of dihydrocodeine versus methadone as an alternative maintenance treatment for opiate dependence: A randomized controlled trial., Addiction, 2006, 101, 12, 1752-1759, doi: 10.1111/j.1360-0443.2006.01603.x.

Additional files

Editorial Notes