Alcohol Dependence
Conditions
Keywords
Alcohol Dependence, Family Medicine Setting, University of North Carolina at Chapel Hill
Brief summary
This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.
Detailed description
Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote abstinence, with few reported side effects. A limitation of these studies, however, has been their lack of generalizability due to restrictive inclusion and exclusion criteria. Furthermore, most of the previous studies of acamprosate have been conducted in Europe, in a different treatment setting from the typical American Family Medicine center, where alcohol dependent patients are most likely to be first identified in the U.S. The present study is designed to determine the efficacy of acamprosatefor alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions-as would also likely occur in a primary care setting. The study will be a 12-week, double-blind, placebo-controlled, randomized trial comparing 666 mg acamprosate t.i.d. to placebo in patients at the UNC Family Medicine Center with alcohol dependence. Subjects will be seen by Family Medicine physicians and receive brief motivational interventions. Primary efficacy will be determined by measuring % days abstinent and secondary outcomes include rates of complete abstinence, % heavy drinking days, CGI and GGT in the acamprosate group compared to the placebo group.
Interventions
The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Sponsors
University of Wisconsin, Milwaukee
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence. * 2\. History of at least 2 heavy drinking days (men \> 5 drinks/day; women \> 4 drinks/day) per week, on average, during the month prior to screening. * 3\. Ability to understand and sign written informed consent. * 4\. Willingness to refrain from drinking for at least three days prior to randomization. * 5\. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.
Exclusion criteria
* 1\. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern. * 2\. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. \[Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.\] * 3\. Suicidal ideation or behavior, history of suicide attempt. * 4\. Renal Impairment; estimated creatinine clearance \<50 ml/min. * 5\. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse. * 6\. Pregnant or breastfeeding women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal). * 7\. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. Individuals may be considered for the trial upon completion of medical detoxification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Dropout | 12 weeks | Percentage of participants who dropped out of study by drug condition |
| Percent Days Abstinent | 12 weeks | %Days without any alcohol consumption over the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Heavy Drinking Days During Trial | 12 weeks | % of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial. |
| Retention | 12 weeks | Number of individuals retained in the trial by acamprosate vs placebo group |
| % Compliant With Medication | 12 weeks | % of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries. |
| Clinical Global Impression Scale | 12 weeks | Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill |
| Percent With Complete Abstinence | 12 weeks | % of subjects with no drinking during the 12 week treatment trial |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1- Acamprosate The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. | 51 |
| 2 - Sugar Pill - Placebo The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incarcerated | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 6 |
| Overall Study | wanted more care | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | 1- Acamprosate | 2 - Sugar Pill - Placebo | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 7.7 | 47.7 years STANDARD_DEVIATION 8.5 | 47.1 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 51 participants | 49 participants | 100 participants |
| Sex: Female, Male Female | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Male | 30 Participants | 32 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 51 | 12 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 49 |
Outcome results
Primary
% Dropout
Percentage of participants who dropped out of study by drug condition
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1- Acamprosate | % Dropout | 21.5 percentage of participants |
| 2 - Sugar Pill - Placebo | % Dropout | 16.3 percentage of participants |
Primary
Percent Days Abstinent
%Days without any alcohol consumption over the treatment period
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1- Acamprosate | Percent Days Abstinent | 40.7 percentage of days | Standard Deviation 30.6 |
| 2 - Sugar Pill - Placebo | Percent Days Abstinent | 41.6 percentage of days | Standard Deviation 33 |
Secondary
Clinical Global Impression Scale
Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1- Acamprosate | Clinical Global Impression Scale | 2.3 units on a scale | Standard Deviation 0.9 |
| 2 - Sugar Pill - Placebo | Clinical Global Impression Scale | 2.4 units on a scale | Standard Deviation 1.2 |
Secondary
% Compliant With Medication
% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1- Acamprosate | % Compliant With Medication | 93.3 percentage of participants |
| 2 - Sugar Pill - Placebo | % Compliant With Medication | 91.6 percentage of participants |
Secondary
% Heavy Drinking Days During Trial
% of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1- Acamprosate | % Heavy Drinking Days During Trial | 15.8 percentage of heavy drinking days | Standard Deviation 21.3 |
| 2 - Sugar Pill - Placebo | % Heavy Drinking Days During Trial | 18.4 percentage of heavy drinking days | Standard Deviation 23.4 |
Secondary
Percent With Complete Abstinence
% of subjects with no drinking during the 12 week treatment trial
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1- Acamprosate | Percent With Complete Abstinence | 5.9 percentage of participants |
| 2 - Sugar Pill - Placebo | Percent With Complete Abstinence | 19.1 percentage of participants |
Secondary
Retention
Number of individuals retained in the trial by acamprosate vs placebo group
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1- Acamprosate | Retention | 39 participants |
| 2 - Sugar Pill - Placebo | Retention | 41 participants |