Effects of tetrodotoxin on cue-induced drug craving in abstinent heroin addicts
| ISRCTN | ISRCTN48774689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48774689 |
| Protocol serial number | 123456 |
| Sponsor | The National Basic Research Program of China (973 Program) (China) |
| Funders | The National Basic Research Program of China (973 Program) (China) (ref: 2007CB512302), The National High Technology Research and Development Program of China (863 Program) (China) (ref: 2006AA02Z4D1), The China-Canada Joint Health Research Program (China) (ref: 30611120528) |
- Submission date
- 18/06/2008
- Registration date
- 10/07/2008
- Last edited
- 04/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
National Institute on Drug Dependence
Peking University
38, Xue Yuan Road
Haidian District
Beijing
100083
China
| Phone | +86 (0)10 8280 2459 |
|---|---|
| linlu@bjmu.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind placebo-controlled, between-subjects design |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effects of tetrodotoxin on cue-induced drug craving in abstinent heroin addicts |
| Study objectives | The purpose of this double-blind placebo-controlled study was to assess the effect of a single intramuscular dose of tetrodotoxin (TTX) on cue-induced craving and anxiety in abstinent heroin addicts. |
| Ethics approval(s) | Ethics approval received from the Human Investigation Committee of the Peking University Health Centre on the 27th June 2007 (ref: 21). |
| Health condition(s) or problem(s) studied | Addiction |
| Intervention | The abstinent heroin addicts were randomly assigned to three treatment groups: 1. Placebo 2. 5 μg tetrodotoxin 3. 10 μg tetrodotoxin Each treatment was administered once only, intramuscularly, before exposure to a neutral video or a heroin-related video. Craving, anxiety, blood pressure, and heart rate were measured pre- and post-exposure. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tetrodotoxin |
| Primary outcome measure(s) |
Cue-induced craving and anxiety. |
| Key secondary outcome measure(s) |
Heart rate and blood pressure. |
| Completion date | 20/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Men or non-pregnant/nursing women 18 - 45 years old 2. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM- IV) criteria for heroin dependence, but opiate-free for at least one month 3. No use of cocaine and other drugs |
| Key exclusion criteria | 1. Current or past cardiovascular disease 2. History of allergy (food, medicine) 3. Current or past psychiatric illness 4. Neurological signs and/or history of neurological disease 5. Current medical illness 6. Participation in other clinical trials of medications within the past three month |
| Date of first enrolment | 08/02/2008 |
| Date of final enrolment | 20/03/2008 |
Locations
Countries of recruitment
- China
Study participating centre
100083
China
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 | 01/06/2009 | 04/06/2019 | Yes | No |
Editorial Notes
04/06/2019: Total final enrolment and publication reference were added.
