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Nicotine AddictionEarly Phase 1DCS/PSRTNCT01944423

Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

A Early Phase 1 study testing d-cycloserine, Nicotine replacement therapy and Panic and Smoking Reduction Treatment in people with Nicotine Addiction and Panic Attack, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine Addiction, Panic Attack
What is being tested?
d-cycloserine, Nicotine replacement therapy and Panic and Smoking Reduction Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteUnited States
Study dates
Oct 2013to Oct 2018
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

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.

Being tested
d-cycloserine, Pill Placebo, Nicotine replacement therapy, Panic and Smoking Reduction Treatment
Medical subject headings
Tobacco Use Disorder, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • d-cycloserineDrug

    Also called d-cycloserine; DCS

    d-cycloserine is a medication thought to be associated with fear extinction.

  • Pill PlaceboDrug

    Also called sugar pill

  • Nicotine replacement therapyDrug

    Also called patch, NRT, nicoderm,

    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 TreatmentBehavioural

    Also called PSRT, CBT, cognitive behavioral therapy, panic reduction, smoking cessation

    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.

Study groups in NCT01944423
Study groupRoleWhat they receive
PSRT_DCSExperimentalIndividuals 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).
Receives: Drug: d-cycloserine; Drug: Nicotine replacement therapy; Behavioral: Panic and Smoking Reduction Treatment
PSRT_PBOPlacebo comparatorIndividuals 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).
Receives: Drug: Pill Placebo; Drug: Nicotine replacement therapy; Behavioral: Panic and Smoking Reduction Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed from week 3-29, week 29 reported

Secondary outcomes (2)

  1. 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).

    Measured: Assessed from week 3-29, week 7 reported (end of treatment)

  2. 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.

    Measured: Assessed from week 3-29, week 29 reported (6-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944423
Sponsor's protocol ID
R34DA034658
Acronym
DCS/PSRT
Status last verified
May 2021
First submitted
10 Sep 2013
Last updated
19 May 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 32004998

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing d-cycloserine, Nicotine replacement therapy and Panic and Smoking Reduction Treatment in people with Nicotine Addiction and Panic Attack, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Abstinence (time frame: Assessed from week 3-29, week 29 reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01944423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.

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