Condition category
Mental and Behavioural Disorders
Date applied
21/12/2008
Date assigned
23/01/2009
Last edited
23/01/2009
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 Xueyuan Road
Beijing
100191
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stress enhances retrieval of heroin-related memories through concurrent effect on glucocorticoids and norepinephrine in abstinent heroin addicts

Acronym

Study hypothesis

We hypothesised that stress may enhance retrieval of heroin-related memories in heroin addicts and this effect involved the noradrenergic systems and glucocorticoids.

Ethics approval

The study was approved by Human Investigating Committee of the Peking University Health Center on the 20th August 2007 (ref: 21); clinical trial (medicine) check in 2007.

Study design

Double-blind randomised placebo-controlled design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Heroin addiction

Intervention

There are three groups:
1. Propranolol 40 mg
2. Cortisol 50 mg
3. Placebo

The trial is an acute administration drug and all of them were given orally once.

Intervention type

Drug

Phase

Not Applicable

Drug names

Propranolol, cortisol

Primary outcome measures

The effect of propranolol and cortisol administration on heroin-related memory retrieval in abstinent heroin addicts, measured 1 hour after the medicine treatment.

Secondary outcome measures

The effect of propranolol and cortisol on salivary cortisol levels 1 hour after drug administration.

Overall trial start date

20/01/2008

Overall trial end date

30/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged from 20 to 40 years, male only
2. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for heroin dependence with opiate free for at least one month
3. No use of other drugs

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

102 participants

Participant exclusion criteria

1. Current use of any medications
2. Current DSM-IV diagnosis of any affective, anxiety, or psychotic disorder
3. Current dependence on any substance besides heroin and nicotine (based on DSM-IV criteria)
4. Risk factors for untoward side effects from propranolol and cortisol (i.e., irregular heartbeats, history of cardiogenic shock, history of severe heart failure, asthma, fungal infections, hyperlipidaemia, history of hypertension, or abnormal electrocardiogram [ECG] or other laboratory findings)

Recruitment start date

20/01/2008

Recruitment end date

30/08/2008

Locations

Countries of recruitment

China

Trial participating centre

National Institute on Drug Dependence
Beijing
100191
China

Sponsor information

Organisation

The National Basic Research Program of China (973 Program) (China)

Sponsor details

-
Beijing
10083
China

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)

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