CompletedPhase 4ACTRN12609000138280

A randomised controlled trial of unsupervised buprenorphine-naloxone versus wait list contol for heroin addiction

A randomised controlled trial to evaluate the effect of unsupervised buprenorphine-naloxone on heroin use in heroin addicts compared to heroin use in addicts who remain on the wait-list to receive opiate-substitution therapy.

Sponsor

Hunter New England Area Health Service, Drug and Alcohol Clinical Services

Enrollment

50 participants

Start Date

Apr 28, 2009

Study Type

Interventional

Conditions

heroin addiction

Summary

The clinical trial would compare heroin use in a group of patients randomly allocated to receive unsupervised dosing with buprenorphine-naloxone to a group of patients remaining on wait list for a 12 week period (when this group would then be offered substitution treatment). The study will also assess adverse events that may be related to providing unsupervised dosing with buprenorphine-naloxone.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether buprenorphine-naloxone (a medication that reduces heroin cravings) given without daily supervision is effective for people dependent on heroin. Adults aged 18 and over who are dependent on heroin and have used it at least 20 days in the past month may be eligible. Participants are randomly assigned to receive the medication or be placed on a waiting list.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients randomised to the treatment group will receive daily buprenorphine naloxone for a period of 3 months administered as tablets of Suboxone delviered sublingually. During week 1 of dosing, the daily dose will be escalated from 4mg up to 16mg per day and tolerability to the dose will be determined, The maximum tolerable daily dose level will then be given for the duration of the treatment period. Dose tolerability will also be continually reviewed and doses modfied as required during this period. Half of the initial dose of Suboxone tablets on the first day of treatment will be delivered to the patient in the clinic. For the remainder of the treatment period patients will be supplied with enough Suboxone tablets to enable them to self administer their own daily doses for the following week. At the commencement of each week during the treatment period patients will return to the clinic and be reviewed and receive enough take home doses for the following week of treatment.

Locations(1)

NSW, Australia

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ACTRN12609000138280