NCT01944423

Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nicotine Addiction
• Panic Attack

Interventions

Type	Name	Description
DRUG	d-cycloserine	d-cycloserine is a medication thought to be associated with fear extinction.
DRUG	Pill Placebo
DRUG	Nicotine replacement therapy	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.
BEHAVIORAL	Panic and Smoking Reduction Treatment	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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2013-09-17
• Last updated: 2021-05-19
• Results posted: 2021-05-19

Locations

1 site across 1 country: United States