Nicotine AddictionPhase 1NCT01062932
Investigation of Cycloserine as a Smoking Cessation Treatment
A Phase 1 study testing Cycloserine in people with Nicotine Addiction, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there is an urgent need for new treatment approaches that can improve treatment outcomes. One new approach involves facilitation of extinction of conditioned responses through the use of d-cycloserine, a partial agonist at the NMDA… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Want to participate in a treatment aimed at helping them stop smoking cigarettes
- Be English-speaking volunteers between 18-55 years of age
- Meet DSM-IV TR criteria for current nicotine dependence and smoke >10 cigarettes per day for the past year
- Meet DSM-IV TR criteria for cocaine dependence, but not seeking treatment for cocaine dependence at the time of study
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator
Who cannot join
- Meet DSM-IV TR criteria for abuse or dependence on alcohol or other drugs, except for nicotine and cocaine
- Have psychiatric disorders, such as: current major depression as assessed by SCID; lifetime history of schizophrenia, other psychotic illness, or bipolar illness as assessed by SCID; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of seizure disorder or severe head injury
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Be pregnant or nursing. Female participants must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry and at the end of study participation
- Have no history of adverse response to d-cycloserine
- Have any other illness, condition, or use of medications, which in the opinion of the P.I. and/or the admitting physician would preclude safe and/or successful completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Cycloserine Enhancement of Extinction Learning
Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there is an urgent need for new treatment approaches that can improve treatment outcomes. One new approach involves facilitation of extinction of conditioned responses through the use of d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful for the treatment of several anxiety disorders. For example, treatment with d-cycloserine enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments for drug dependence by enhancing extinction of conditioned responses to drug cues. In this Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept study to examine effects of treatment with d-cycloserine for facilitating extinction of craving provoked by exposure to cigarette smoking cues. The benefits of this treatment approach together with cognitive behavioral treatment for reducing cigarette smoking will then be determined. Smoking cues will be presented using an established virtual reality simulator(Bordnick et al 2004; Bordnick et al 2005a)
Read the detailed description
See brief summary
- Conditions
- Nicotine Addiction
- Being tested
- Cycloserine, Placebo
- Keywords
- Cycloserine, Nicotine, Smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloserineDrug
Also called d-cycloserine, Seromycin
Oral administration of cycloserine medication (50 mg administered prior to each exposure treatment) on Day 1, 4, 7, and 10 of the study
PlaceboDrug
Also called Sugar pill
Oral administration of matching placebo pill on Days 1, 4, 7, and 10
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cycloserine | Active comparator | Not described Receives: Drug: Cycloserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of four weeks of single dose treatment with d-cycloserine or placebo on craving elicited by exposure to "virtual reality" smoking cues
The study will evaluate the effects of treatment with d-cycloserine (50mg administered prior to each exposure treatment) or placebo (n=20 per cell), on the efficacy exposure therapy using a virtual reality cue for smoking cessation when combined with cognitive behavioral therapy (CBT). Craving ratings will be assessed using standard questionnaires, which will be completed prior to and following virtual reality cue exposure. Smoking cessation and cocaine use will be assessed at three follow-up visits.
Secondary outcomes (1)
The effects of four weeks of single dose treatment with d-cycloserine or placebo, exposure to virtual reality smoking cues, and provision of manual-driven cognitive behavioral treatment on frequency of cigarette smoking and cocaine use
Study sessions will include assessment of urinary cocaine and breath CO, and participants will self-report cigarette smoking and cocaine use over the previous week. Smoking cessation and cocaine use will also be assessed at three follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062932
- Sponsor's protocol ID
- H-23305
- Other IDs
- R21DA023588, DPMC
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2010
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycloserine Enhancement of Extinction Learning
- ClinicalTrials.gov ID
- NCT01062932
- Acronym / sponsor ID
- H-23305
- Conditions
- Nicotine Addiction
- Keywords
- Cycloserine, Nicotine, Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there is an urgent need for new treatment approaches that can improve treatment outcomes. One new approach involves facilitation of extinction of conditioned responses through the use of d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful for the treatment of several anxiety disorders. For example, treatment with d-cycloserine enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments for drug dependence by enhancing extinction of conditioned responses to drug cues. In this Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept study to examine effects of treatment with d-cycloserine for facilitating extinction of craving provoked by exposure to cigarette smoking cues. The benefits of this treatment approach together with cognitive behavioral treatment for reducing cigarette smoking will then be determined. Smoking cues will be presented using an established virtual reality simulator(Bordnick et al 2004; Bordnick et al 2005a)
Detailed description
See brief summary
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cycloserine | Active comparator | Drug: Cycloserine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Want to participate in a treatment aimed at helping them stop smoking cigarettes
- Be English-speaking volunteers between 18-55 years of age
- Meet DSM-IV TR criteria for current nicotine dependence and smoke >10 cigarettes per day for the past year
- Meet DSM-IV TR criteria for cocaine dependence, but not seeking treatment for cocaine dependence at the time of study
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator
Key exclusion criteria (6 listed)
- Meet DSM-IV TR criteria for abuse or dependence on alcohol or other drugs, except for nicotine and cocaine
- Have psychiatric disorders, such as: current major depression as assessed by SCID; lifetime history of schizophrenia, other psychotic illness, or bipolar illness as assessed by SCID; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of seizure disorder or severe head injury
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Be pregnant or nursing. Female participants must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry and at the end of study participation
- Have no history of adverse response to d-cycloserine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycloserineAlso: d-cycloserine, SeromycinOral administration of cycloserine medication (50 mg administered prior to each exposure treatment) on Day 1, 4, 7, and 10 of the study | Drug | Cycloserine |
| PlaceboAlso: Sugar pillOral administration of matching placebo pill on Days 1, 4, 7, and 10 | Drug | Placebo |
Primary outcome
The effects of four weeks of single dose treatment with d-cycloserine or placebo on craving elicited by exposure to "virtual reality" smoking cues
The study will evaluate the effects of treatment with d-cycloserine (50mg administered prior to each exposure treatment) or placebo (n=20 per cell), on the efficacy exposure therapy using a virtual reality cue for smoking cessation when combined with cognitive behavioral therapy (CBT). Craving ratings will be assessed using standard questionnaires, which will be completed prior to and following virtual reality cue exposure. Smoking cessation and cocaine use will be assessed at three follow-up visits.
1 secondary outcome
The effects of four weeks of single dose treatment with d-cycloserine or placebo, exposure to virtual reality smoking cues, and provision of manual-driven cognitive behavioral treatment on frequency of cigarette smoking and cocaine use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
Related trials for Nicotine Addiction
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cycloserine in people with Nicotine Addiction, run by Baylor College of Medicine 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 5 inclusion and 6 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 27 Jul 2012. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effects of four weeks of single dose treatment with d-cycloserine or placebo on craving elicited by exposure to "virtual reality" smoking cues. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2012.