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Completed

NCT Number: NCT04133974

Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts

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.

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Key information

Conditions

Heroin Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methadone induced memory retrieval-extinction procedure

Behavioral

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 outcomes

  1. 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").

  2. 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.

Secondary outcomes

  1. 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)

    Heart rate will be monitored immediately before and after cue exposure

  2. 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)

    Blood pressure will be monitored immediately before and after cue exposure.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Dependence, China

Other

Registry information

Official study title

A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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