A double-blind, placebo-controlled parallel-group pilot study of the effectiveness of D-cycloserine in reducing craving during cue-exposure therapy in abstinent alcohol-dependant subjects

ISRCTN ISRCTN04481866
DOI https://doi.org/10.1186/ISRCTN04481866
Secondary identifying numbers N0038174882
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
10/09/2012
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

Prof David Nutt
Scientific

Psychopharmacology Unit
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom

Email david.j.nutt@bristol.ac.uk

Study information

Study designDouble-blind placebo-controlled parallel-group pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesCan D-cycloserine improve extinction of cue-induced craving in alcohol dependence?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and Behavioural Disorders: Alcohol dependence
InterventionRCT: [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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)D-cycloserine
Primary outcome measureSpielberger State and Trait Anxiety Inventory, Beck Depression Inventory, OCDS. Alcohol Urge Questionnaire, and visual analogue scores to rate craving and mood.
Secondary outcome measuresNot provided at time of registration
Overall study start date19/12/2005
Completion date24/04/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexMale
Target number of participants24
Key inclusion criteria24 abstinent alcohol dependant males who attend the Bristol Area Specialist Alcohol Service. 12 in each group, D-cycloserine and placebo
Key exclusion criteria1. 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
Date of first enrolment19/12/2005
Date of final enrolment24/04/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychopharmacology Unit
Bristol
BS1 3NY
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2011 Yes No