Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
D-cycloserine
Primary outcome measure
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 study start date
19/12/2005
Overall study end date
24/04/2009
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No |