Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
10/09/2012
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

Prof David Nutt

ORCID ID

Contact details

Psychopharmacology Unit
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom
david.j.nutt@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0038174882

Study information

Scientific title

Acronym

Study hypothesis

Can D-cycloserine improve extinction of cue-induced craving in alcohol dependence?

Ethics approval

Not provided at time of registration

Study design

Double-blind placebo-controlled parallel-group pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Mental and Behavioural Disorders: Alcohol dependence

Intervention

RCT: [A] D-cycloserine; [B] placebo.

Screening visit: medical and psychiatric history, physical exam, biochemistry and haematology, liver function, drugs of abuse screen and ECG. Personality Questionnaire - TPQ and EPQ, Severity of Alcohol Dependence questionnaire and a semi-structured consumption of alcohol questionnaire. Instruction given for a standardised breakfast on the testing days. Modified Stroop test given.

Test day 1: Baseline blood pressure and heart rate recordings, urine screen for drugs of abuse, breath alcohol determination and subjective ratings obtained from breakfasted participants. Participants complete outcome measures. After medication, graded cue exposure when peak plasma level reached.

Test Day 2: as Test Day 1

Test Day 3: as test day 1 but no medication given to either group.

Intervention type

Drug

Phase

Not Specified

Drug names

D-cycloserine

Primary outcome measures

Spielberger State and Trait Anxiety Inventory, Beck Depression Inventory, OCDS. Alcohol Urge Questionnaire, and visual analogue scores to rate craving and mood.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/12/2005

Overall trial end date

24/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

24 abstinent alcohol dependant males who attend the Bristol Area Specialist Alcohol Service. 12 in each group, D-cycloserine and placebo

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

24

Participant exclusion criteria

1. Substance misuse or dependence (other than alcohol)
2. Major psychiatric morbidity such as psychosis
3. Clinically significant abnormality on physical examination or investigation
4. Pregnancy or breast feeding
5. Taking acamprosate, disulfiram or naltrexone

Recruitment start date

19/12/2005

Recruitment end date

24/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychopharmacology Unit
Bristol
BS1 3NY
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21318564

Publication citations

  1. Results

    Watson BJ, Wilson S, Griffin L, Kalk NJ, Taylor LG, Munafò MR, Lingford-Hughes AR, Nutt DJ, A pilot study of the effectiveness of D-cycloserine during cue-exposure therapy in abstinent alcohol-dependent subjects., Psychopharmacology (Berl.), 2011, 216, 1, 121-129, doi: 10.1007/s00213-011-2199-2.

Additional files

Editorial Notes