Tobacco Use DisorderPhase 1NCT00136747
The Effects of Memantine and Bupropion on Acute, Reinforcing, and Conditioned Effects of Cigarettes - 1
A Phase 1 study testing Memantine and bupropion in people with Tobacco Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
One of nicotine's effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment of nicotine addiction. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Memantine and bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2009
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Who cannot join
- DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
Show all 11Show fewer
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders
- History of allergic reaction to any of the study medications
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Developing Medication For Tobacco Addiction: NMDA Agents
One of nicotine's effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment of nicotine addiction. The purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of tobacco addiction. The investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.
Read the detailed description
Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. Neurotransmission at NMDA receptors in the brain is associated with learning and memory and has been linked to many of nicotine's effects on humans. It is possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction.
The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. Specifically, the study will assess the effect of memantine, a non-competitive NMDA antagonist, versus bupropion, a medication currently used to facilitate smoking cessation, on various behavioral aspects related to smoking behavior, including reinforcement and cue-reactivity.
This double-blind, randomized assignment study will consist of three distinct phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 3 days of inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days. At these visits, compliance and side effects of medication will be monitored, smoking diaries will be collected, and medication will be dispensed. During the inpatient period participants will be allowed to smoke only at designated times. A variety of assessment will be conducted, including abstinence symptoms, acute effects of cigarettes, responses to cigarette cues, and cigarette self-administration.
- Conditions
- Tobacco Use Disorder
- Being tested
- Memantine, bupropion, placebo
- Keywords
- tobacco use
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Two capsules of Memantine twice daily for 12 days.
bupropionDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| BUPROPION | Experimental | Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing Receives: Drug: bupropion |
| placebo | Experimental | Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing Receives: Drug: placebo |
| memantine | Experimental | Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to cigarette cues
Measured: Days 11-13
Smoking behavior
Measured: Days 11-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Bisaga, New York State Psychiatric Institute
- Investigators
- Adam Bisaga, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136747
- Sponsor's protocol ID
- #4725(1)
- Other IDs
- R01DA017572, R01DA017572-01, DPMC
- Status last verified
- May 2018
- First submitted
- 25 Aug 2005
- Last updated
- 21 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Medication For Tobacco Addiction: NMDA Agents
- ClinicalTrials.gov ID
- NCT00136747
- Acronym / sponsor ID
- #4725(1)
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Aug 2005 (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.
One of nicotine's effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment of nicotine addiction. The purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of tobacco addiction. The investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.
Detailed description
Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. Neurotransmission at NMDA receptors in the brain is associated with learning and memory and has been linked to many of nicotine's effects on humans. It is possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction.
The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. Specifically, the study will assess the effect of memantine, a non-competitive NMDA antagonist, versus bupropion, a medication currently used to facilitate smoking cessation, on various behavioral aspects related to smoking behavior, including reinforcement and cue-reactivity.
This double-blind, randomized assignment study will consist of three distinct phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 3 days of inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days. At these visits, compliance and side effects of medication will be monitored, smoking diaries will be collected, and medication will be dispensed. During the inpatient period participants will be allowed to smoke only at designated times. A variety of assessment will be conducted, including abstinence symptoms, acute effects of cigarettes, responses to cigarette cues, and cigarette self-administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BUPROPION | Experimental | Drug: bupropionParticipants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing |
| placebo | Experimental | Drug: placeboParticipants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing |
| memantine | Experimental | Drug: MemantineParticipants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Key exclusion criteria (11 listed)
- DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
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 |
|---|---|---|
| MemantineTwo capsules of Memantine twice daily for 12 days. | Drug | memantine |
| bupropion | Drug | BUPROPION |
| placebo | Drug | placebo |
Primary outcome
Response to cigarette cues
Time frame: Days 11-13
Smoking behavior
Time frame: Days 11-13
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 21 May 2018.
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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.
Adam Bisaga, M.D. principal investigator
New York State Psychiatric Institute
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 Memantine and bupropion in people with Tobacco Use Disorder, run by New York State Psychiatric Institute 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 11 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 21 May 2018. 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. 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?
Response to cigarette cues (time frame: Days 11-13). The study lists 2 primary outcomes in all. 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 21 May 2018.