Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts

NCT ID: NCT04133974

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-20
• Study Completion Date: 2019-04-20

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.

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.

Conditions

Heroin Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Methadone

The subjects take methadone as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Methadone-10min-Extinction

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

Group Type: EXPERIMENTAL

methadone induced memory retrieval-extinction procedure

Intervention Type: 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.

Methadone-6h-Extinction

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

Group Type: SHAM_COMPARATOR

methadone induced memory retrieval-extinction procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Dependence, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NIDD12035

Identifier Type: -

Identifier Source: org_study_id