NCT01047956

Brief Summary

Evaluation whether higher retention rate is in those of combined methadone with N-Acetyl-Cysteine compared to those with methadone alone during a six-month study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 5, 2010

Last Update Submit

January 13, 2010

Conditions

Opioids Use

Keywords

MethadoneNACopioids

Study Arms (2)

MethNAC

EXPERIMENTAL

Methadone and N-acetylcysteine for opioids abstaining

Drug: Methadone; NAC

Methadone

ACTIVE COMPARATOR

Methadone alone

Drug: Methadone

Interventions

Methadone; NACDRUG

Methadone NAC

MethNAC
MethadoneDRUG

Methadone

Methadone

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-65 years old, all genders.
  • Psychiatry doctor diagnosed who met DSMIV-TR criteria opioid addiction or opioid abusing.
  • Participants need to understand procedures and assays of this experiment.
  • Participants are willing to accept methadone substitutive abstaining program.
  • Participants are willing to provide small amount of blood for testing.
  • Participants are voluntarily to join interview(s), approximately 30-45min.

You may not qualify if:

  • Participants have respiratory distress or other respiratory system illnesses.
  • Participants have serious illness and possible die within 1 year or intensive care needed within 6 month.
  • Participants have been diagnosed cardio-vascular disease recently.
  • Participants have allergy to N-acetylcysteine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Tsuo-Hung Lan, MD., PhD.

    Taichung Veterans General Hospital

    STUDY DIRECTOR

Central Study Contacts

Tsuo-Hung Lan, MD., PhD.

CONTACT

04-23592525

Chia-Fen Chang, MD.

CONTACT

04-23592525

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 13, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

TW(1)