Effects of tetrodotoxin on cue-induced drug craving in abstinent heroin addicts
| ISRCTN | ISRCTN48774689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48774689 |
| Secondary identifying numbers | 123456 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Lin Lu
Scientific
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
| Study design | Double blind placebo-controlled, between-subjects design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tetrodotoxin |
| Primary outcome measure | Cue-induced craving and anxiety. Both the primary and secondary outcomes were measured at 0 minutes (baseline, before TTX administration), 60 minutes (1 hour after TTX administration), 65 minutes (immediately after the first video presentation), 75 minutes (before the second video presentation), and 80 minutes (immediately after the second video presentation). |
| Secondary outcome measures | Heart rate and blood pressure. Both the primary and secondary outcomes were measured at 0 minutes (baseline, before TTX administration), 60 minutes (1 hour after TTX administration), 65 minutes (immediately after the first video presentation), 75 minutes (before the second video presentation), and 80 minutes (immediately after the second video presentation). |
| Overall study start date | 08/02/2008 |
| Completion date | 20/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Forty-five participants |
| 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
National Institute on Drug Dependence
Beijing
100083
China
100083
China
Sponsor information
The National Basic Research Program of China (973 Program) (China)
Government
Government
-
Bejing
100083
China
| jcc973@vip.sina.com | |
| Website | http://www.973.gov.cn/ |
"ROR" |
https://ror.org/027s68j25 |
Funders
Funder type
Government
The National Basic Research Program of China (973 Program) (China) (ref: 2007CB512302)
No information available
The National High Technology Research and Development Program of China (863 Program) (China) (ref: 2006AA02Z4D1)
No information available
The China-Canada Joint Health Research Program (China) (ref: 30611120528)
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 | 01/06/2009 | 04/06/2019 | Yes | No |
Editorial Notes
04/06/2019: Total final enrolment and publication reference were added.
