Managing Alcoholism in People Who Do Not Respond to Naltrexone
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Naltrexone; placebo; Medication Management (MM); Combined Behavioral Intervention (CBI); Telephone Counseling
Intervention description: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.; placebo comparer for 16 weeks in phase 2.; Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.; 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.; Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcoholism; alcohol abuse; therapy; drug resistance; naltrexone; patient care management; human subject

Summary:

      This is a study involving treatment for alcohol dependence (alcoholism). The study will
      combine motivational enhancement therapy and cognitive behavioral therapy (combined
      behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment
      with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in
      motivating patients to greater medication adherence and may address psychosocial factors that
      may limit the effects of naltrexone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Current DSM-IV diagnosis of alcohol dependence using the MINI.

          -  Meets the following drinking criteria as measured by the Timeline Followback (TLFB): *
             drank within 30 days of randomization; * reports a minimum of 48 standard alcoholic
             drinks (avg. 12 drinks/wk.) in a consecutive 30-day period over the 90-day period
             prior to intake; and * has 2 or more days of heavy drinking (defined as over 5 drinks
             per day in males and over 4 drinks per day in females) in this same pre-treatment
             period, prior to intake.

          -  Prior to starting NTX, scores below 8 on the Clinical Inventory of Withdrawal from
             Alcohol (CIWA), and at least 3 consecutive days of abstinence (2 days abstinence will
             be permitted with approval by the principal investigator) directly prior to
             randomization, as determined by Subject report and breathalyzer measures

          -  Speaks, understands and prints in English.

        Exclusion Criteria:

          -  Has abused or been dependent on opiates in the past 12 months, or evidence of opiate
             use in month prior to treatment, as assessed by subject report and intake urine drug
             screen. Use of prescription opioids prior to treatment entry is allowed at the
             discretion of the investigator. However, subjects must be free from use at the time of
             randomization.

          -  Meets DSM IV criteria for current dependence, abuse, or dependence in partial
             remission on any substance other than alcohol (except nicotine and marijuana).
             Subjects who test positive on the urine drug screen (with the exception of THC) at the
             initial visit (a repeat UDSis permitted in cases that are not clear. The repeat UDS
             should be at least 5 days after the initial test)

          -  Has a lifetime DSM-IV diagnosis of schizophrenia or any psychotic disorder. Has a
             current DSM-IV diagnosis of post-traumatic stress disorder (PTST) or bipolar disorder,
             or any disorder that may interfere with study participation, at the discretion of the
             investigator.

          -  Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at
             least 5 times normal, or elevated bilirubin (of 1.3 or higher), as evidenced by the
             most recent lab results prior to randomization. (documentation of Gilberts syndrome
             will not constitute an exclusion despite elevated bilirubin).

          -  Has evidence of significant hematological, pulmonary, endocrine, cardiovascular, renal
             or gastrointestinal disease that the principal investigator considers a risk to
             participation.

          -  Has taken any psychotropic medications (or disulfiram) regularly within the last seven
             days prior to randomization or needs immediate treatment with a psychotropic
             medication (with the exception of detoxification medications or benadryl used
             sparingly for sleep). The required washout period for fluoxetine (Prozac®) is 14 days
             prior to randomization, and the required washout period for other psychotropic
             medications is 7 days prior to randomization.

          -  Has taken any detoxification medication on the day of randomization.

          -  Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months,
             is nursing, or is not using an effective contraceptive method if the subject is of
             child-bearing potential.