Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine (DCS/PSRT)

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Panic Attack; Nicotine Addiction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01944423

R34DA034658

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

53 participants in 2 patient groups, including a placebo group

PSRT_DCS

Experimental group

Description:

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).

Treatment:

Drug: Nicotine replacement therapy

Behavioral: Panic and Smoking Reduction Treatment

Drug: d-cycloserine

PSRT_PBO

Placebo Comparator group

Description:

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).

Treatment:

Drug: Pill Placebo

Drug: Nicotine replacement therapy

Behavioral: Panic and Smoking Reduction Treatment