Back to resultsMethadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts
Primary Purpose
Heroin Dependence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methadone induced memory retrieval-extinction procedure
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Sham Comparator
Arm Label
Methadone
Methadone-10min-Extinction
Methadone-6h-Extinction
Arm Description
The subjects take methadone as usual.
The subjects were given extinction training 10 min following methadone administration.
The subjects were given extinction training 6h following methadone administration.
Outcomes
Primary Outcome Measures
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").
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.
Secondary Outcome Measures
cue induced heart rate change
Heart rate will be monitored immediately before and after cue exposure
cue induced blood pressure change
Blood pressure will be monitored immediately before and after cue exposure.
Full Information
NCT ID
NCT04133974
First Posted
October 14, 2019
Last Updated
October 17, 2019
Sponsor
National Institute on Drug Dependence, China
1. Study Identification
Unique Protocol Identification Number
NCT04133974
Brief Title
Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts
Official Title
A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 20, 2015 (Actual)
Primary Completion Date
April 23, 2017 (Actual)
Study Completion Date
April 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Dependence, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
No Intervention
Arm Description
The subjects take methadone as usual.
Arm Title
Methadone-10min-Extinction
Arm Type
Experimental
Arm Description
The subjects were given extinction training 10 min following methadone administration.
Arm Title
Methadone-6h-Extinction
Arm Type
Sham Comparator
Arm Description
The subjects were given extinction training 6h following methadone administration.
Intervention Type
Behavioral
Intervention Name(s)
methadone induced memory retrieval-extinction procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of cue induced heroin craving
Description
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").
Time Frame
Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Title
change of negative urinary morphine test
Description
All the participants will be required to have urine tests for morphine during screening, weekly during intervention and monthly during follow-up.
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)
Secondary Outcome Measure Information:
Title
cue induced heart rate change
Description
Heart rate will be monitored immediately before and after cue exposure
Time Frame
Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Title
cue induced blood pressure change
Description
Blood pressure will be monitored immediately before and after cue exposure.
Time Frame
Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts
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