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
Scientific
Psychopharmacology Unit
Dorothy Hodgkin Building
Whitson Street
Bristol
BS1 3NY
United Kingdom
| david.j.nutt@bristol.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| 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 |
| Completion date | 24/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Psychopharmacology Unit
Bristol
BS1 3NY
United Kingdom
BS1 3NY
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
