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NCT01400243 · ClinicalTrials.gov registry record · Phase 4

Nicotine Patch for Marijuana Withdrawal

A Phase 4 study, sponsored by Southern Illinois University Carbondale.

Completed
Registry status
Phase 4
Development phase
127
Enrollment target

NCT01400243: Completed Phase 4 study, sponsored by Southern Illinois University Carbondale.

NCT01400243 is a Phase 4 study that has completed, run by Southern Illinois University Carbondale. The registered enrollment target is 127 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01400243, a Phase 4 study, has completed, sponsored by Southern Illinois University Carbondale.

COMPLETED
Registry status
Phase 4
Development phase
127 participants
Enrollment target

Study Summary

The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.

Primary Outcome

POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.

Interventions

  • DRUG Placebo Patch
  • DRUG Nicotine

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2011-04
Est. Completion 2014-06
Phase Phase 4

What the finished NCT01400243 record still lists

NCT01400243 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

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

NCT01400243 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01400243 about?

NCT01400243 is a clinical study titled "Nicotine Patch for Marijuana Withdrawal". The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medicati...

What is the current status of trial NCT01400243?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2011-04. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01400243?

The interventions under investigation include: Placebo Patch (DRUG), Nicotine (DRUG).

Who is sponsoring clinical trial NCT01400243?

This trial is sponsored by Southern Illinois University Carbondale, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01400243's enrollment target sits among peer trials

127 639th of 2000 higher than 1,355 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01400243, the US trial registry maintained by the National Library of Medicine. NCT01400243 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.