Stress and retrieval of heroin-related memories in abstinent heroin addicts
| ISRCTN | ISRCTN48521078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48521078 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/12/2008
- Registration date
- 23/01/2009
- Last edited
- 04/07/2019
- 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 Xueyuan Road
Beijing
100191
China
Study information
| Study design | Double-blind randomised placebo-controlled design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Propranolol, cortisol |
| Primary outcome measure | 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 study start date | 20/01/2008 |
| Completion date | 30/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 102 participants |
| 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 |
Locations
Countries of recruitment
- China
Study participating centre
National Institute on Drug Dependence
Beijing
100191
China
100191
China
Sponsor information
The National Basic Research Program of China (973 Program) (China)
Government
Government
-
Beijing
10083
China
| 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)
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 | 01/02/2010 | 04/07/2019 | Yes | No |
Editorial Notes
04/07/2019: Publication reference and total final enrolment added.
