Contact information
Type
Scientific
Primary contact
Prof Lin Lu
ORCID ID
Contact details
National Institute on Drug Dependence
Peking University
38
Xue Yuan Road
Haidian District
Beijing
100083
China
+86 (0)10 8280 2459
linlu@bjmu.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
123456
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Human Investigation Committee of the Peking University Health Centre on the 27th June 2007 (ref: 21).
Study design
Double blind placebo-controlled, between-subjects design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Tetrodotoxin
Primary outcome measures
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 trial start date
08/02/2008
Overall trial end date
20/03/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Forty-five participants
Participant 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
Recruitment start date
08/02/2008
Recruitment end date
20/03/2008
Locations
Countries of recruitment
China
Trial participating centre
National Institute on Drug Dependence
Beijing
100083
China
Sponsor information
Organisation
The National Basic Research Program of China (973 Program) (China)
Sponsor details
-
Bejing
100083
China
jcc973@vip.sina.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The National Basic Research Program of China (973 Program) (China) (ref: 2007CB512302)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National High Technology Research and Development Program of China (863 Program) (China) (ref: 2006AA02Z4D1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The China-Canada Joint Health Research Program (China) (ref: 30611120528)
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary