CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 53 enrolled
Drug / intervention
d-cycloserine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01944423
NCT01944423Early Ph 1Completed

Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

University of Texas at Austin·interventional·Posted Sep 17, 2013·Updated May 19, 2021

In Brief

A Early Phase 1 clinical trial evaluating d-cycloserine, Pill Placebo, and 2 other interventions for Nicotine Addiction and Panic Attack. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting treatment of smoking cessation for individuals with panic attacks. The investigators hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence greater smoking abstinence rates and decreased panic symptoms after receiving a combined CBT-based treatment for smokers with panic attacks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 12.8 years ago

Interventions

d-cycloserinedrug

d-cycloserine is a medication thought to be associated with fear extinction.

Pill Placebodrug

Nicotine replacement therapydrug

All participants will receive Nicoderm CQ®, 24-hour transdermal nicotine patches and will be educated about the use of the patch at the session immediately prior to quit date. They will be instructed to apply one patch daily, beginning on quit date (week 5). Participants will use the 3-step tapering Nicoderm process (21-mg, 14-mg, and 7-mg). This regimen has been used in previous trials with a similar formulation of the patch (Fiore, 2000). A meta-analysis found no differences in outcome between 16- or 24-hour patches (Fiore et al., 1994). Participants who continue to smoke or lapse after quit day will not be instructed to discontinue the patch until their smoking level reaches 4 cigarettes/day for 4 days. Smokers who lapse during treatment will be encouraged to set a new quit date and continue their cessation attempt.

Panic and Smoking Reduction Treatmentbehavioral

PSRT incorporates elements of standard smoking cessation treatment (i.e., counseling plus NRT) with procedures for reducing panic and enhancing tolerance to withdrawal sensations. Written therapist and patient manuals will be used and followed at all times to ensure standardized delivery of the treatment. Interventions that uniquely focus on addressing panic, fears and intolerance of anxiety, bodily-related sensations, and affect-relevant withdrawal symptoms include: (1) interoceptive exposure; (2) corrective information about anxiety and cognitive interventions designed to teach patients alternatives to catastrophic misinterpretations of the sensations and their feared consequences; and (3) situational exposure.