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NCT01539941 · ClinicalTrials.gov registry record · Phase 1

Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care

A Phase 1 study, sponsored by The National Center on Addiction and Substance Abuse at Columbia University.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01539941: Completed Phase 1 study, sponsored by The National Center on Addiction and Substance Abuse at Columbia University.

NCT01539941 is a Phase 1 study that has completed, run by The National Center on Addiction and Substance Abuse at Columbia University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01539941, a Phase 1 study, has completed, sponsored by The National Center on Addiction and Substance Abuse at Columbia University.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations.

Primary Outcome

Brief qualitative interviews will be designed and administered to the on-site psychiatrist and family therapists to capture judgments about the viability and acceptability of MIP compared to previous site practices, as well as its perceived short- and long-term safety and effectiveness for ASU/ADHD cases. A parallel qualitative interview will be administered to teens and caregivers at 3-month follow-up. MIP teens will also receive incentives to maintain medication diaries of daily pill intake, u

Interventions

  • BEHAVIORAL Medication integration protocol

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2011-08
Est. Completion 2014-05
Phase Phase 1

What the finished NCT01539941 record still lists

NCT01539941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Medication integration protocol is the first listed.

NCT01539941 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01539941 about?

NCT01539941 is a clinical study titled "Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care". The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a p...

What is the current status of trial NCT01539941?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-08. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01539941?

The interventions under investigation include: Medication integration protocol (BEHAVIORAL).

Who is sponsoring clinical trial NCT01539941?

This trial is sponsored by The National Center on Addiction and Substance Abuse at Columbia University, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01539941's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01539941, the US trial registry maintained by the National Library of Medicine. NCT01539941 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.