An interventional study of methadone induced memory retrieval-extinction procedure in Heroin Dependence, sponsored by National Institute on Drug Dependence, China. Completed. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by National Institute on Drug Dependence, China · Not applicable, Interventional, and Treatment
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.
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.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 87 is close to the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →National Institute on Drug Dependence, China is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects take methadone as usual.
The subjects were given extinction training 10 min following methadone administration.
Behavioral: methadone induced memory retrieval-extinction procedure
The subjects were given extinction training 6h following methadone administration.
Behavioral: methadone induced memory retrieval-extinction procedure
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.
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").
Time frame: 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.
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)
cue induced heart rate change
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)
cue induced blood pressure change
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)
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Dependence, China