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NCT00218634 · ClinicalTrials.gov registry record · NA

Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
89
Enrollment target

NCT00218634: Completed NA study, sponsored by Massachusetts General Hospital.

NCT00218634 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00218634, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
89 participants
Enrollment target

Study Summary

Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001). Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.

Primary Outcome

Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

Interventions

  • BEHAVIORAL ETAU
  • BEHAVIORAL CBT-AD

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2005-02
Est. Completion 2009-07
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT00218634 record still lists

NCT00218634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which ETAU is the first listed.

NCT00218634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00218634 about?

NCT00218634 is a clinical study titled "Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1". Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatme...

What is the current status of trial NCT00218634?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2005-02. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00218634?

The interventions under investigation include: ETAU (BEHAVIORAL), CBT-AD (BEHAVIORAL).

Who is sponsoring clinical trial NCT00218634?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00218634's enrollment target sits among peer trials

89 972nd of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00218634, the US trial registry maintained by the National Library of Medicine. NCT00218634 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.