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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSRT_DCS | Experimental | 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 | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine | Drug | d-cycloserine is a medication thought to be associated with fear extinction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32004998 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PSRT_DCS | 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). d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction. |
| FG001 | PSRT_PBO | 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). Pill Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PSRT_DCS | 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). d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat analysis | Posted | Number | percentage of participants | Assessed from week 3-29, week 29 reported |
|
Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PSRT_DCS | 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). d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chipped back bone | General disorders | Systematic Assessment | Chipped bone in back reported at follow-up appointment. The event was deemed unrelated to study procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jasper Smits | Univeristy of Texas at Austin | 512-475-8095 | smits@utexas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2017 | Dec 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2017 | May 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| D000095488 | Nicotine Replacement Therapy |
| D057968 | Transdermal Patch |
| D009538 | Nicotine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Pill Placebo | Drug |
|
|
| Nicotine replacement therapy | Drug | 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. |
|
|
| Panic and Smoking Reduction Treatment | Behavioral | 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. |
|
|
| 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) |
| BG001 | PSRT_PBO | 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). Pill Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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). Pill Placebo |
|
|
|
| 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). | Intent to treat analysis | Posted | Mean | Standard Deviation | unstandardized units | 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. | Intent to treat analysis | Posted | Mean | Standard Deviation | unstandardized units | Assessed from week 3-29, week 29 reported (6-month follow-up) |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 2 |
| 27 |
| EG001 | PSRT_PBO | 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). Pill Placebo | 0 | 26 | 0 | 26 | 3 | 26 |
|
| Pericarditis | Cardiac disorders | Systematic Assessment | Pericarditis reported at follow-up appointment. The event was deemed unrelated to study procedures. |
|
| Anxiety | Psychiatric disorders | Systematic Assessment | Participant reported elevated anxiety symptoms after 1st administration study medication. Deemed possibly related to study procedures and medication was discontinued. |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Participant was diagnosed with anemia during follow-up. AE was unlikely to be related to study procedures. |
|
| Migraine | General disorders | Systematic Assessment | Participant reported a migraine at follow-up appointment. AE was unlikely to be related to study procedures. |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004864 | Equipment and Supplies |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D011725 | Pyridines |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |