Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts

Sponsor
National Institute on Drug Dependence, China (Other)
Overall Status
Completed
CT.gov ID
NCT04133974
Collaborator
(none)
87
3
41

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: methadone induced memory retrieval-extinction procedure
N/A

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

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Novel Methadone-induced Memory Retrieval-extinction Procedure to Prevent Heroin Craving and Relapse
Actual Study Start Date :
Nov 20, 2015
Actual Primary Completion Date :
Apr 23, 2017
Actual Study Completion Date :
Apr 20, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Methadone

The subjects take methadone as usual.

Experimental: Methadone-10min-Extinction

The subjects were given extinction training 10 min 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.

Sham Comparator: Methadone-6h-Extinction

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.

Outcome Measures

Primary Outcome Measures

  1. change of cue induced heroin craving [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 [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 Outcome Measures

  1. cue induced heart rate change [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Institute on Drug Dependence, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Institute on Drug Dependence, China
ClinicalTrials.gov Identifier:
NCT04133974
Other Study ID Numbers:
  • NIDD12035
First Posted:
Oct 21, 2019
Last Update Posted:
Oct 21, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2019