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
Protocol serial number	N0038174882
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Double-blind placebo-controlled parallel-group pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Can 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) studied	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 / device / biological / vaccine name(s)	D-cycloserine
Primary outcome measure(s)	Spielberger State and Trait Anxiety Inventory, Beck Depression Inventory, OCDS. Alcohol Urge Questionnaire, and visual analogue scores to rate craving and mood.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	24/04/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	24
Key inclusion criteria	24 abstinent alcohol dependant males who attend the Bristol Area Specialist Alcohol Service. 12 in each group, D-cycloserine and placebo
Key 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
Date of first enrolment	19/12/2005
Date of final enrolment	24/04/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Psychopharmacology Unit

Bristol
BS1 3NY
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	01/07/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes