Heroin DependenceNCT04133974
Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts
A study testing methadone induced memory retrieval-extinction procedure in people with Heroin Dependence, run by National Institute on Drug Dependence, China.
Trial summary
The study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. Male participants aged 18-55 years old and prescribed MMT to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- methadone induced memory retrieval-extinction procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2015to 20 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- met the diagnostic criteria of heroin dependence according to DSM-IV
- were prescribed methadone maintenance treatment (MMT) and took it regularly
- no change in city of residence for at least 1 year
- had normal blood pressure and heart rate
- had negative urine morphine screening test
- primary-school level education
- provide signed consent
Who cannot join
- other substance abuse(except nicotine)
- had a current or past history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV) AxisⅠdisorders
- had clinically evident physical disorders
- neurological signs and/or history of neurological disease
- noncompliance with the procedure
About this study
Official title: A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse
The study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. Male participants aged 18-55 years old and prescribed MMT to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10 minutes plus extinction, or receive methadone plus 6 hours plus extinction. The intervention persisted 3 times per week for 4 weeks. Then the subjects were followed up once a month for cue induced heroin craving and relapse.
Read the detailed description
In the present study, we explored the effect retrieval-extinction procedure on heroin craving and relapse in heroin addicts using the methadone (a commonly used µ-opioid receptor agonist) instead of heroin as the trigger to reactivate drug memories. The subjects were randomly divided into 3 groups, in which they received methadone alone or extinction sessions 10 min or 6 hours after methadone administration. The extinction sessions were given 3 times per week for 4 weeks, each lasted for 30 min. During the extinction procedure, the subjects were exposed to images, heroin paraphernalia and mimic heroin. Subjective craving, morphine urine test and physiological responses were recorded monthly for 4 months.
- Conditions
- Heroin Dependence
- Being tested
- methadone induced memory retrieval-extinction procedure
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methadone induced memory retrieval-extinction procedureBehavioural
Drug memory is not invariably stable and can be induced transiently labile again by drug-related cues or drug itself, which is termed as 'reconsolidation'. Previously we and other groups have demonstrated that extinction coincided with reconsolidation weakened the drug memory and decreased drug craving and relapse. In the present study, we tried to interfere the methadone-induced heroin addiction memory reconsolidation by extinction given at different times following methadone administration.
| Study group | Role | What they receive |
|---|---|---|
| Methadone | No intervention | The subjects take methadone as usual. |
| Methadone-10min-Extinction | Experimental | The subjects were given extinction training 10 min following methadone administration. Receives: Behavioral: methadone induced memory retrieval-extinction procedure |
| Methadone-6h-Extinction | Sham comparator | The subjects were given extinction training 6h following methadone administration. Receives: Behavioral: methadone induced memory retrieval-extinction procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cue induced heroin craving
Heroin craving will be assessed using a visual analog scale (VAS), i.e., an undivided line marked at the left and right ends with 0 ("not at all") and 10 ("extremely high").
Measured: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
change of negative urinary morphine test
All the participants will be required to have urine tests for morphine during screening, weekly during intervention and monthly during follow-up.
Measured: Baseline (Day 0), weekly during intervention(1, 2, 3 and 4 week) and monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Secondary outcomes (2)
cue induced heart rate change
Heart rate will be monitored immediately before and after cue exposure
Measured: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
cue induced blood pressure change
Blood pressure will be monitored immediately before and after cue exposure.
Measured: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start20 Nov 2015
- Primary completion23 Apr 2017
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Dependence, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133974
- Sponsor's protocol ID
- NIDD12035
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse
- ClinicalTrials.gov ID
- NCT04133974
- Acronym / sponsor ID
- NIDD12035
- Conditions
- Heroin Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- National Institute on Drug Dependence, ChinaUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 23 Apr 2017 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. Male participants aged 18-55 years old and prescribed MMT to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10 minutes plus extinction, or receive methadone plus 6 hours plus extinction. The intervention persisted 3 times per week for 4 weeks. Then the subjects were followed up once a month for cue induced heroin craving and relapse.
Detailed description
In the present study, we explored the effect retrieval-extinction procedure on heroin craving and relapse in heroin addicts using the methadone (a commonly used µ-opioid receptor agonist) instead of heroin as the trigger to reactivate drug memories. The subjects were randomly divided into 3 groups, in which they received methadone alone or extinction sessions 10 min or 6 hours after methadone administration. The extinction sessions were given 3 times per week for 4 weeks, each lasted for 30 min. During the extinction procedure, the subjects were exposed to images, heroin paraphernalia and mimic heroin. Subjective craving, morphine urine test and physiological responses were recorded monthly for 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methadone | No intervention | –The subjects take methadone as usual. |
| Methadone-10min-Extinction | Experimental | Behavioral: methadone induced memory retrieval-extinction procedureThe subjects were given extinction training 10 min following methadone administration. |
| Methadone-6h-Extinction | Sham comparator | Behavioral: methadone induced memory retrieval-extinction procedureThe subjects were given extinction training 6h following methadone administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- met the diagnostic criteria of heroin dependence according to DSM-IV
- were prescribed methadone maintenance treatment (MMT) and took it regularly
- no change in city of residence for at least 1 year
- had normal blood pressure and heart rate
- had negative urine morphine screening test
Key exclusion criteria (5 listed)
- other substance abuse(except nicotine)
- had a current or past history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV) AxisⅠdisorders
- had clinically evident physical disorders
- neurological signs and/or history of neurological disease
- noncompliance with the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methadone induced memory retrieval-extinction procedureDrug memory is not invariably stable and can be induced transiently labile again by drug-related cues or drug itself, which is termed as 'reconsolidation'. Previously we and other groups have demonstrated that extinction coincided with reconsolidation weakened the drug memory and decreased drug craving and relapse. In the present study, we tried to interfere the methadone-induced heroin addiction memory reconsolidation by extinction given at different times following methadone administration. | Behavioural | Methadone-10min-Extinction, Methadone-6h-Extinction |
Primary outcome
change of cue induced heroin craving
Time frame: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Heroin craving will be assessed using a visual analog scale (VAS), i.e., an undivided line marked at the left and right ends with 0 ("not at all") and 10 ("extremely high").
change of negative urinary morphine test
Time frame: Baseline (Day 0), weekly during intervention(1, 2, 3 and 4 week) and monthly during follow-up for 4 months (2, 3, 4 and 5 month)
All the participants will be required to have urine tests for morphine during screening, weekly during intervention and monthly during follow-up.
2 secondary outcomes
cue induced heart rate change
Time frame: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
cue induced blood pressure change
Time frame: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing methadone induced memory retrieval-extinction procedure in people with Heroin Dependence, run by National Institute on Drug Dependence, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of cue induced heroin craving (time frame: Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.