Condition category
Mental and Behavioural Disorders
Date applied
18/06/2008
Date assigned
10/07/2008
Last edited
10/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.973.gov.cn/

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

Publication citations

Additional files

Editorial Notes