Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts

Heroin Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133974
• Other study ID #: NIDD12035
• Status: Completed
• Phase: N/A
• Start date: November 20, 2015
• Est. completion date: April 20, 2019

Study information

• Verified date: October 2019
• Source: National Institute on Drug Dependence, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 20, 2019
• Est. primary completion date: April 23, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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) Axis?disorders

• had clinically evident physical disorders

• neurological signs and/or history of neurological disease

• noncompliance with the procedure

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Dependence, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	cue induced heart rate change	Heart rate will be monitored immediately before and after cue exposure	Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)
Secondary	cue induced blood pressure change	Blood pressure will be monitored immediately before and after cue exposure.	Baseline (Day 0 ), post-intervention (1 month), monthly during follow-up for 4 months (2, 3, 4 and 5 month)