Nicotine Use DisorderPhase 2NCT00257894
Baclofen Effects on Smoking Urge and Withdrawal
A Phase 2 study testing Baclofen in people with Nicotine Use Disorder and Nicotine Dependence, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Use Disorder, Nicotine Dependence, Smoking
- What is being tested?
- Baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2008
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-
Who cannot join
- Planning to attempt smoking cessation within the next 4 months
- Weight less than 110 lbs. or above 220 lbs.
- Use of tobacco products other than cigarettes in the previous month.
- History of: Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke, brain injury, Alzheimers Disease, encephalitis, meningitis, seizure disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder, or Schizotypal Disorder.
- Current alcohol and/or drug use disorder as indicated by a screening questionnaire, past treatment for alcohol or substance use problems unless in remission(clean and sober for past year or more) or intention to seek treatment in the next 6 months for alcohol or substance use problems.
- For women: Pregnancy, nursing, not using a reliable form of birth control.
Show all 9Show fewer
- Allergy to baclofen, Lioresal, or Kemstro.
- Taking the following medications: antidepressants(excluding selective serotonin reuptake inhibitors), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockers.
- Lives with someone enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Providence
Providence, Rhode Island, 02908
About this study
The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.
Read the detailed description
OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. The specific objectives of the present application are to investigate the dose-response effects of baclofen (a gamma-aminobutyric acid B agonist), 1) on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours of smoking deprivation. RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4 hours of deprivation. METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and who are motivated for future smoking cessation. On Day 0, a baseline session will occur after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be repeated after the final medication dose has been stabilized for at least 3 days and after 4 hours of supervised smoking deprivation has occurred. Medication differences in urge and withdrawal and in the reinforcement value of smoking cigarettes will be investigated. Dependent measures of urge and withdrawal will be by self-report. The dependent measure of reinforcement value is the ratio of choices for cigarette puffs versus money during a subsequent 2-1/2 hr period. The choice procedure will clarify the relative reinforcement value of smoking while controlling for non-specific decreases in general activity level resulting from sedation. Nicotine self-administration during the medication period will be quantified using saliva cotinine, as a secondary effect. CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less suffering and mortality and in considerable savings in health care costs associated with cardiovascular disease, pulmonary disorders, and cancer.
- Being tested
- Baclofen, Placebo
- Keywords
- Baclofen, Conditioning, Classical, 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.
BaclofenDrug
Also called Seroquel
Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).
PlaceboDrug
Matched placebo capsules containing inert filler taken orally for a total of 12 days
| Study group | Role | What they receive |
|---|---|---|
| Baclofen condition | Experimental | Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12. Receives: Drug: Baclofen |
| Placebo condition | Placebo comparator | Placebo capsules identical to active medication, 3/day for 12 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on Questionnaire of Smoking Urges
Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge).
These data are only available on the subset of participants who participated through Day 10.
Measured: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Minnesota Nicotine Withdrawal Questionnaire
Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal).
These data are only available on the subset of participants who participated through Day 10.
Measured: Day 10
Secondary outcomes (2)
Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.
Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse).
These data are only available on the subset of participants who participated through Day 10..
Measured: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Cigarette Choice Task
At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed).
These data are only available on the subset of participants who participated through Day 10.
Measured: Tenth day of medication titration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Enrollment was completed with insufficient sample size for publishable results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Damaris Rohsenow, PhD, Principal investigator, VA Medical Center, Providence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257894
- Sponsor's protocol ID
- NEUA-029-04F
- Status last verified
- Oct 2015
- First submitted
- 21 Nov 2005
- Last updated
- 4 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen Effects on Smoking Urge and Withdrawal
- ClinicalTrials.gov ID
- NCT00257894
- Acronym / sponsor ID
- NEUA-029-04F
- Keywords
- Baclofen, Conditioning, Classical, Nicotine, Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was completed with insufficient sample size for publishable results
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Nov 2005 (estimated)
- Results
- Posted 4 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.
Detailed description
OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. The specific objectives of the present application are to investigate the dose-response effects of baclofen (a gamma-aminobutyric acid B agonist), 1) on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours of smoking deprivation. RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4 hours of deprivation. METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and who are motivated for future smoking cessation. On Day 0, a baseline session will occur after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be repeated after the final medication dose has been stabilized for at least 3 days and after 4 hours of supervised smoking deprivation has occurred. Medication differences in urge and withdrawal and in the reinforcement value of smoking cigarettes will be investigated. Dependent measures of urge and withdrawal will be by self-report. The dependent measure of reinforcement value is the ratio of choices for cigarette puffs versus money during a subsequent 2-1/2 hr period. The choice procedure will clarify the relative reinforcement value of smoking while controlling for non-specific decreases in general activity level resulting from sedation. Nicotine self-administration during the medication period will be quantified using saliva cotinine, as a secondary effect. CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less suffering and mortality and in considerable savings in health care costs associated with cardiovascular disease, pulmonary disorders, and cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen condition | Experimental | Drug: BaclofenBaclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12. |
| Placebo condition | Placebo comparator | Drug: PlaceboPlacebo capsules identical to active medication, 3/day for 12 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-
Key exclusion criteria (9 listed)
- Planning to attempt smoking cessation within the next 4 months
- Weight less than 110 lbs. or above 220 lbs.
- Use of tobacco products other than cigarettes in the previous month.
- History of: Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke, brain injury, Alzheimers Disease, encephalitis, meningitis, seizure disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder, or Schizotypal Disorder.
- Current alcohol and/or drug use disorder as indicated by a screening questionnaire, past treatment for alcohol or substance use problems unless in remission(clean and sober for past year or more) or intention to seek treatment in the next 6 months for alcohol or substance use problems.
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 |
|---|---|---|
| BaclofenAlso: SeroquelDosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12). | Drug | Baclofen condition |
| PlaceboMatched placebo capsules containing inert filler taken orally for a total of 12 days | Drug | Placebo condition |
Primary outcome
Total Score on Questionnaire of Smoking Urges
Time frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10.
Minnesota Nicotine Withdrawal Questionnaire
Time frame: Day 10
Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal). These data are only available on the subset of participants who participated through Day 10.
2 secondary outcomes
Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.
Time frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.
Cigarette Choice Task
Time frame: Tenth day of medication titration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nicotine Use Disorder
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.
Damaris Rohsenow, PhD principal investigator
VA Medical Center, Providence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baclofen in people with Nicotine Use Disorder and Nicotine Dependence, run by VA Office of Research and Development 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 Nov 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Nov 2015). 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?
Total Score on Questionnaire of Smoking Urges (time frame: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.). 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 4 Nov 2015.