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

Primary Purpose

Nicotine Addiction, Panic Attack

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
d-cycloserine
Pill Placebo
Nicotine replacement therapy
Panic and Smoking Reduction Treatment
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PSRT_DCS

PSRT_PBO

Arm 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).

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).

Outcomes

Primary Outcome Measures

Smoking Abstinence
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

Anxiety Sensitivity Mechanistic Target
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).
Panic Symptoms Mechanistic Target
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.

Full Information

First Posted
September 10, 2013
Last Updated
May 17, 2021
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT01944423
Brief Title
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
Acronym
DCS/PSRT
Official Title
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Panic Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSRT_DCS
Arm Type
Experimental
Arm 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).
Arm Title
PSRT_PBO
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
d-cycloserine
Other Intervention Name(s)
d-cycloserine; DCS
Intervention Description
d-cycloserine is a medication thought to be associated with fear extinction.
Intervention Type
Drug
Intervention Name(s)
Pill Placebo
Other Intervention Name(s)
sugar pill
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement therapy
Other Intervention Name(s)
patch, NRT, nicoderm,
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Panic and Smoking Reduction Treatment
Other Intervention Name(s)
PSRT, CBT, cognitive behavioral therapy, panic reduction, smoking cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking Abstinence
Description
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.
Time Frame
Assessed from week 3-29, week 29 reported
Secondary Outcome Measure Information:
Title
Anxiety Sensitivity Mechanistic Target
Description
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).
Time Frame
Assessed from week 3-29, week 7 reported (end of treatment)
Title
Panic Symptoms Mechanistic Target
Description
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.
Time Frame
Assessed from week 3-29, week 29 reported (6-month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32004998
Citation
Smits JAJ, Zvolensky MJ, Otto MW, Piper ME, Baird SO, Kauffman BY, Lee-Furman E, Alavi N, Dutcher CD, Papini S, Rosenfield B, Rosenfield D. Enhancing panic and smoking reduction treatment with D-Cycloserine: A pilot randomized clinical trial. Drug Alcohol Depend. 2020 Mar 1;208:107877. doi: 10.1016/j.drugalcdep.2020.107877. Epub 2020 Jan 22.
Results Reference
derived

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Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

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