Please select the eligibility criteria that correspond to the clinical trial below.
Title: COMBINE: Effect of Combined Pharmacotherapies and Behavioral Interventions
Brief Summary: Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.


Options:
A: Inclusion Criteria:

* Meet criteria for primary alcohol dependence including loss of control of drinking
* No more than one previous inpatient medical detoxification
* Consumes on average 5 standard drinks for men and 4 standard drinks for women
* Able to maintain sobriety for 4 days (with or without detox medications).
* Able to read and understand questionnaires and Informed Consent
* Lives within 50 miles of the study site

Exclusion Criteria:

* Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
* Ever abused opiates
* Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen.
* Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
* Has current suicidal or homicidal ideation
* Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
* Current use of disulfiram.
* Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence.
* Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control.
* Has current charges pending for a violent crime (not including DUI related offenses).
* Does not have a stable living situation and a reliable source of collateral reporting.
* Has taken an opiate antagonist drug in the last month.
* Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.
B: Inclusion Criteria:

* At least 18 and not older than 70 years
* Good knowledge of the German language
* The criteria of an alcohol dependence after DSM IV and ICD 10 fulfill
* To the recruiting time alkoholabstinently living, i.e. after successful alcohol decontamination, the patients must have understood the meaning and consequence of the study and have delivered before beginning of study your written agreement to the participation.
* Negative drug screening regarding Benzodiazepines and Opiates.
* With Females either o at least 1 year Menopause or after Sterilization or contraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormone plaster, hormone spiral at least 1 month before study inclusion or use of the double barrier method with Spermiziddiaphragma plus condom use or renouncement of sexual intercourse during the entire study duration and resolution a pregnancy to avoid with negative β-HCG-test

Exclusion Criteria:

* Alcohol withdrawal syndrome beginning or existing
* Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps
* Specific ones behavior or deep-psychological single therapy or manual-led group therapies parallel to the clinical study
* Any further substance dependence except nicotine and/or Caffeine dependence A abuse according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.
* Idiopathic epilepsy, not however admitted alcohol withdrawal convulsions
* Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. Polyneuropathie
* current CO-medication by means of medicines, which can affect significantly withdrawal symptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics, antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparable effect mechanism) or Acamprosat, Disulfiram, or further substances, which can affect glutamaterge, dopaminerge, cholinergic, serotonerge or opiode system the GABAerge,
* Contraindications or heavy side effects in relation to the study medication, hypersensitivity opposite Pyrrolidonderivate
* Pregnancy or quiet time or insufficient Contraception
* Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
* Acute Suizidalität, not convincingly arrangementable
* Severe internal illnesses, e.g. Pancreatitis, pneumonia, cardiac infarct, gastrointestinal bleedings etc.)
* Severe kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers) and/or creatinin Clearance of small 30ml/min
* Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).
C: Inclusion Criteria:

* Have a current diagnosis of alcohol dependence
* drink an average of 28 or more standard drinking units/week for women or 35 or more standard drinking units/week for men
* have a desire to stop drinking completely or to reduce alcohol consumption with the possible long-term goal of abstinence
* have a body mass index of 18 or more
* sexually active women capable of having children must be using an acceptable method of birth control
* must be in generally good health.

Exclusion Criteria:

* No current or recent (within 6 months) diagnosis of other substance abuse or dependence
* no inpatient or outpatient counseling for alcohol dependence other than Alcoholics Anonymous within 4 weeks
* not more than 4 past failed inpatient treatments attempts for alcohol dependence
* no other psychiatric disorder that requires treatment with medication or therapy
* no current probation or parole requirement or legally mandated requirement to participate in an alcohol treatment program.
D: Inclusion criteria

The following inclusion criteria are to be met:

1. Male and female outpatients \> 18 years of age.
2. Participants will have a current DSM-IV diagnosis of alcohol dependence.
3. Participants will have signed a witnessed informed consent.
4. Participants must have been drinking a minimum of \> 14 drinks (females) or \> 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and have two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
5. Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA \< 8 prior to randomization.
6. Participants can be abstinent for a maximum of 21 days prior to randomization.
7. Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period.
8. Participants who are able to identify at least one "locator" person to assist in tracking the participant for follow-up assessment.
9. Participants who are able to speak and understand English.

Exclusion criteria

The following exclusion criteria rule out participants:

1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder requiring medication.
2. Participants requiring concomitant therapy with any medications that pose safety issues (see Appendix B).
3. Participants with a current diagnosis of dependence on any drug except for nicotine, cannabis, and alcohol, or habitual caffeine use. If there is a positive urine screen the participant can be retested after the (metabolic) interval appropriate to that drug. If the second urine drug screen is positive the person is excluded.
4. Participants who meet DSM-IV criteria for opiate dependence or abuse within the past 6 months, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids.
5. Participants who have significant medical disorders that will increase the potential risk of study treatment or interfere with study participation, and participants with sensitivity to study medications or related drugs as evidenced by adverse drug experience, especially with opiate-containing analgesics, opioid antagonists, or acamprosate.
6. Participants with abnormal AST or ALT (more than 3 times the upper limit of the normal range(ULN)) or elevated bilirubin (more than 10% above the ULN). Tests may be repeated if initial results are out of range.
7. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
8. Participants who intend to engage in additional formal treatment for alcohol-related problems, or who intend to continue in current treatment for alcohol-related problems during the active treatment period. Self-help treatments are not considered formal treatment.
9. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
10. Participants who have prior use of study medication(s) in the last 30 days.

Any question concerning the interpretation of or application of the inclusion/exclusion criteria will be referred to the medical expert at the Coordinating Center. If he is unavailable, the question will be referred to the Chairperson of the Treatment Subcommittee.

Answer: D