Stress and retrieval of heroin-related memories in abstinent heroin addicts

ISRCTN	ISRCTN48521078
DOI	https://doi.org/10.1186/ISRCTN48521078
Protocol serial number	N/A
Sponsor	The National Basic Research Program of China (973 Program) (China)
Funder	The National Basic Research Program of China (973 Program) (China)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Lin Lu
Scientific

National Institute on Drug Dependence
Peking University
38 Xueyuan Road
Beijing
100191
China

Primary study design	Interventional
Study design	Double-blind randomised placebo-controlled design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Stress enhances retrieval of heroin-related memories through concurrent effect on glucocorticoids and norepinephrine in abstinent heroin addicts
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Propranolol, cortisol
Primary outcome measure(s)	The effect of propranolol and cortisol administration on heroin-related memory retrieval in abstinent heroin addicts, measured 1 hour after the medicine treatment.
Key secondary outcome measure(s)	The effect of propranolol and cortisol on salivary cortisol levels 1 hour after drug administration.
Completion date	30/08/2008

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	102
Total final enrolment	102
Key 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
Key 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)
Date of first enrolment	20/01/2008
Date of final enrolment	30/08/2008

National Institute on Drug Dependence

Beijing
100191
China

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010	04/07/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

04/07/2019: Publication reference and total final enrolment added.