Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

Early Phase 1

Completed

Conditions: Panic Attack
Nicotine Addiction

Interventions: Drug: Pill Placebo
Drug: d-cycloserine
Drug: Nicotine replacement therapy
Behavioral: Panic and Smoking Reduction Treatment

Registration Number: NCT01944423

Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Male and female patients ages 18-65 capable of providing informed consent
Willing and able to provide informed consent, attend all study visits and comply with the protocol
Daily smoker for at least one year
Currently smoke an average of at least 8 cigarettes per day
Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
Evidence of panic attack within the past year and endorsement of smoking as an emotion regulation strategy (i.e., score at least a 78 on the SAEQ).

Exclusion Criteria

Subjects who do not use smoking as an emotion regulation strategy
Current diagnosis of a psychotic, eating, developmental or bipolar disorder
Significant suicide risk as determined by structured interview
Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
Current use of isoniazid or ethionamide compounds
A history of significant medical condition and/or be deemed as currently unhealthy in the context of a complete physical examination
Limited mental competency and the inability to give informed, voluntary, written consent to participate
Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
Use of other tobacco products
Plans to move outside of the immediate area in the next six months
Insufficient command of the English language

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSRT_DCS	Nicotine replacement therapy	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
PSRT_PBO	Nicotine replacement therapy	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
PSRT_DCS	Panic and Smoking Reduction Treatment	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
PSRT_PBO	Pill Placebo	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
PSRT_DCS	d-cycloserine	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
PSRT_PBO	Panic and Smoking Reduction Treatment	Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	Assessed from week 3-29, week 29 reported	Smoking status will be assessed at baseline and each of the follow-up assessments using point prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.

Secondary Outcome Measures

Name	Time	Method
Panic Symptoms Mechanistic Target	Assessed from week 3-29, week 29 reported (6-month follow-up)	Panic disorder severity scale is a 7-item measure assessing the severity of seven features of panic: frequency of panic attacks, distress during panic attacks, anticipatory anxiety, agoraphobic fear and avoidance, interoceptive fear and avoidance, impairment of work functioning, and impairment of social functioning. Items are rated on a five-point Likert scale ranging from 0 (none) to 4 (extreme), with a total possible score of 28. Higher scores indicate greater severity and impairment.
Anxiety Sensitivity Mechanistic Target	Assessed from week 3-29, week 7 reported (end of treatment)	Anxiety sensitivity was assessed using the Anxiety Sensitivity Index-3, which is an 18 item measure of fear of bodily sensations. Participants rated their concern regarding the possible negative consequences of internal anxiety-related sensations. Scores range from 0-72, with higher scores indicated greater sensitivity to bodily sensations (worse outcome).