Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Condition: Benzodiazepine Dependence; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Gabapentin; Placebo
Intervention description: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule.; placebo comparator appears identical to active medication and is prescribed with an identical dosing schedule with a maximum dose of 400mg taken three times per day
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Benzodiazepine; Gabapentin; Methadone

Summary:

      The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in
      methadone maintenance patients. A second aim is to study the effects of gabapentin on
      craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing
      benzodiazepines. The proposed protocol is a randomized, double-blind, placebo-controlled
      pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone
      maintenance patients. All subjects will receive weekly manual-guided psychotherapy directed
      at achieving abstinence and improving current functioning. The primary outcome measure,
      benzodiazepine use, will be assessed weekly by a combination of self-report (time line
      follow-back method) and urine toxicology. Associated psychological symptoms of craving, mood,
      anxiety, and sleep disturbance, will be assessed by a combination of clinician and self-rated
      instruments.

      The investigators hypothesize that individuals receiving methadone maintenance treatment who
      are abusing (nonprescribed use) benzodiazepines have difficulty in reducing or discontinuing
      benzodiazepine use because of the significant anxiety, mood, and sleep disturbance symptoms
      that accompany reduction in use. Gabapentin, an anticonvulsant which has anxiolytic and
      sedating properties, may alleviate the symptoms associated with a reduction in benzodiazepine
      abuse and make the achievement of abstinence more likely when administered in the setting of
      an active psychotherapy condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between the ages of 18-65 who meet DSM-IV criteria for benzodiazepine
             abuse or dependence, and opioid dependence, and are being treated for opioid
             dependence with methadone.

          -  Individuals seeking treatment for benzodiazepine abuse or dependence.

          -  Individuals capable of giving informed consent and capable of complying with study
             procedures.

          -  Individuals must have current benzodiazepine use.

          -  Individuals must report using, benzodiazepines an average > 4 days per week over the
             past 28 days. The average amount of benzodiazepine used per using day must be >
             lorazepam 4 mg/day or its equivalent

             (1 mg lorazepam = 0.25 mg clonazepam = 0.5 mg alprazolam = 5 mg diazepam = 10 mg
             chlordiazepoxide)

          -  Women of child-bearing age will be included provided that they are not pregnant, based
             on the results of a blood pregnancy test done at the time of screening and agree to
             use a method of contraception with proven efficacy and not to become pregnant during
             the study.

        Exclusion Criteria:

          -  Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-TR
             supported by the SCID-I/P that in the investigator's judgment that are unstable or
             would be disrupted by study medication or by an effort to discontinue benzodiazepines.
             Disorders that are stable on psychotherapy or pharmacotherapy will not be
             exclusionary.

          -  Individuals with evidence of acute physiological benzodiazepine withdrawal.

          -  Individuals with a history of seizures during alcohol or sedative-hypnotic withdrawal.

          -  Individuals with a history of requiring pharmacologic detoxification from alcohol or
             sedative-hypnotic agents in the past year.

          -  Individuals meeting DSM IV criteria for current cocaine dependence as their primary
             substance use disorder diagnosis.

          -  Unstable physical disorders that might make participation hazardous such as
             uncontrolled hypertension and tachycardia (SBP > 150 mm Hg, DBP > 90 mm Hg, or a
             sitting quietly HR > 100 bpm), acute hepatitis (patients with chronic mildly elevated
             transaminase levels [2-3 x upper limit of normal] are acceptable) or poorly controlled
             diabetes. Kidney disease or impaired kidney function that would interfere with the
             excretion of gabapentin is exclusionary.

          -  Patients currently taking prescribed psychotropic medications, other than methadone or
             medications prescribed for pain syndromes, that would be disrupted by study medication
             or by an effort to discontinue benzodiazepines. Anticonvulsants prescribed for pain
             syndromes are exclusionary.

          -  Patients with a known sensitivity to gabapentin.

          -  Individuals who have exhibited suicidal or homicidal behavior within the past two
             years or have current active suicidal ideation.

          -  Women who are pregnant or nursing.

          -  Individuals physiologically dependent on any other drugs (excluding nicotine,
             caffeine, methadone).

          -  Individuals currently prescribed gabapentin.