Nicotine Addiction Clinical Trial
— DCS/PSRTOfficial title:
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
Verified date | May 2021 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Assessed from week 3-29, week 29 reported | |
Secondary | 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). | Assessed from week 3-29, week 7 reported (end of treatment) | |
Secondary | 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. | Assessed from week 3-29, week 29 reported (6-month follow-up) |
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