Baclofen Effects on Smoking Urge and Withdrawal

NCT00257894 | Terminated Phase 2 Results

• 1 other identifier: NEUA-029-04F
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Use Disorder; Nicotine Dependence; Smoking; Tobacco Use Disorder

Keywords

Baclofen; Conditioning, Classical; Nicotine; Smoking

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 10

Secondary Outcomes (2)

• Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.

  Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.

• Cigarette Choice Task

  Tenth day of medication titration

Study Arms (2)

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.

Drug: Baclofen

Placebo condition

PLACEBO COMPARATOR

Placebo capsules identical to active medication, 3/day for 12 days.

Drug: Placebo

Interventions

Baclofen DRUG

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).

Also known as: Seroquel

Baclofen condition

Placebo DRUG

Matched placebo capsules containing inert filler taken orally for a total of 12 days

Placebo condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Baclofen; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Damaris J. Rohsenow, Ph.D.
• Organization: Veterans Affairs Medical Center (VAMC), Providence

damaris.rohsenow@va.gov

401-863-6648

Study Officials

• Damaris Rohsenow, PhD

  VA Medical Center, Providence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 4, 2015
• Results First Posted: November 4, 2015

Record last verified: 2015-10

Locations

US (1)