NCT04133974

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

October 14, 2019

Last Update Submit

October 17, 2019

Conditions

Heroin Dependence

Outcome Measures

Primary Outcomes (2)

  • 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").

    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.

    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

    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

    Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)

Study Arms (3)

Methadone

NO INTERVENTION

The subjects take methadone as usual.

Methadone-10min-Extinction

EXPERIMENTAL

The subjects were given extinction training 10 min following methadone administration.

Behavioral: methadone induced memory retrieval-extinction procedure

Methadone-6h-Extinction

SHAM COMPARATOR

The subjects were given extinction training 6h following methadone administration.

Behavioral: methadone induced memory retrieval-extinction procedure

Interventions

methadone induced memory retrieval-extinction procedureBEHAVIORAL

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.

Methadone-10min-ExtinctionMethadone-6h-Extinction

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 21, 2019

Study Start

November 20, 2015

Primary Completion

April 23, 2017

Study Completion

April 20, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share