Alcoholism
Conditions
Keywords
Alcohol, Alcohol abuse, Alcoholism, Alcohol Dependence, Varenicline, Drinking
Brief summary
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as very heavy drinkers).
Interventions
DRUGVarenicline
0.5mg capsules x 2, 2x a day for 12 weeks
DRUGPlacebo
identical matched placebo x 2, 2xday, 13 weeks
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least 18 years of age. 2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence. 3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking. 4. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 5. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. levonorgestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, 9. hormonal vaginal contraceptive ring, and/or 6. Be able to take oral medication and be willing to adhere to the medication regimen 7. Complete all assessments required at screening and baseline. 8. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 9. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study. 10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document. 11. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Percentage of Heavy Drinking Days | Weeks 2-13* | Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks | 97 |
| Sugar Pill Placebo: identical matched placebo x 2, 2xday, 13 weeks | 101 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 8 |
| Overall Study | Outpatient detox | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | schedule conflict | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Sugar Pill | Total | Varenicline |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 12.3 | 45.5 years STANDARD_DEVIATION 11.6 | 46 years STANDARD_DEVIATION 11 |
| Age of onset of regular drinking | 19.3 years STANDARD_DEVIATION 5.5 | 19 years STANDARD_DEVIATION 5.8 | 18.7 years STANDARD_DEVIATION 6.1 |
| Alcohol-related consequences score - ImBIBE | 16.3 score STANDARD_DEVIATION 9.7 | 17 score STANDARD_DEVIATION 9.7 | 17.8 score STANDARD_DEVIATION 9.8 |
| Drinks per day | 12.5 drinks per day STANDARD_DEVIATION 9 | 13 drinks per day STANDARD_DEVIATION 9 | 14 drinks per day STANDARD_DEVIATION 9.3 |
| Drinks per drinking day | 13.6 drinks per drinking day STANDARD_DEVIATION 9 | 14.4 drinks per drinking day STANDARD_DEVIATION 9.3 | 15.3 drinks per drinking day STANDARD_DEVIATION 9.6 |
| Gamma-glutamyl transpeptidase (GGT) | 70.1 IU/L STANDARD_DEVIATION 103.1 | 71.9 IU/L STANDARD_DEVIATION 113.3 | 72.9 IU/L STANDARD_DEVIATION 123.5 |
| Penn Alcohol Craving Scale Score | 16.7 score STANDARD_DEVIATION 6.8 | 17.2 score STANDARD_DEVIATION 6.5 | 17.7 score STANDARD_DEVIATION 6.2 |
| Percent days abstinent | 7.9 percent days abstinent STANDARD_DEVIATION 13.6 | 7.8 percent days abstinent STANDARD_DEVIATION 13 | 7.7 percent days abstinent STANDARD_DEVIATION 12.5 |
| Percent heavy drinking days | 87.2 percent heavy drinking days STANDARD_DEVIATION 16.4 | 87.7 percent heavy drinking days STANDARD_DEVIATION 16.1 | 88.1 percent heavy drinking days STANDARD_DEVIATION 15.8 |
| Region of Enrollment United States | 101 participants | 198 participants | 97 participants |
| Sex: Female, Male Female | 32 Participants | 58 Participants | 26 Participants |
| Sex: Female, Male Male | 69 Participants | 140 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 97 | 90 / 101 |
| serious Total, serious adverse events | 2 / 97 | 2 / 101 |
Outcome results
Primary
Weekly Percentage of Heavy Drinking Days
Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
Time frame: Weeks 2-13*
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Weekly Percentage of Heavy Drinking Days | 37.9 percentage of heavy drinking days | Standard Error 3.6 |
| Sugar Pill | Weekly Percentage of Heavy Drinking Days | 48.4 percentage of heavy drinking days | Standard Error 3.52 |