Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Condition: Benzodiazepine Dependence; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The investigators will recruit individuals with current benzodiazepine abuse or dependence,
      as defined by the DSM-IV, who are receiving methadone maintenance treatment at the Bridge
      Plaza Treatment and Rehabilitation Clinic. The initial step in recruitment for all patients
      will be a referral from a clinic counselor.

      The investigators plan to enroll 86 participants into the study. Both males and females will
      be recruited. The distribution of benzodiazepine abuse in methadone maintenance populations
      with regard to race and gender is not well studied.The investigators expect the gender and
      racial distribution of subjects to reflect the demographic nature of the Bridge Plaza
      Treatment and Rehabilitation Clinic; which is approximately 33% Caucasian, 33%
      African-American, and 33% Hispanic; and 40% female. The investigators will make every effort
      to recruit minority patients in order to ensure the ability to generalize our findings to the
      overall treatment population.

      All patients will begin medication at the start of the study. Subjects will take medication
      twice each day, once in the morning and once in the evening. All tablets (placebo and study
      medication) will be over-capsulated with riboflavin to measure compliance. The placebo group
      will have a dosing schedule that is identical to the gabapentin group (i.e., they will take
      the same number of pills each day). Medication will be dispensed weekly in individual vials
      identified by patient, with dosing instructions written on the outside of the vials. Patients
      in the placebo group will not receive gabapentin at any time during the study. Gabapentin
      will be administered in 400 mg tablets; placebo tablets will appear identical to the
      gabapentin tablets. Gradual increases in medication doses are used in order to minimize side
      effects and enhance compliance. At the start of week 1, the group receiving gabapentin will
      be administered at 400 mg three-times a day. This dose will be increased to 800 mg
      three-times a day at week 2 and increased to 1200 mg three-times a day at the start of week
      3. The dose will continue at 1200 mg three-times a day for weeks 3 through 8. Dose reductions
      for tolerability will be made by the research psychiatrist in coordination with the research
      pharmacy. All patients must take a minimum of gabapentin/placebo 400 mg BID to remain in the
      study.

      Both the active and placebo medication capsules will contain riboflavin, which will allow the
      clinic to verify that the study medication is being taken correctly and absorbed by the body.
      Urine samples obtained weekly will be examined under a UV lamp in order to observe any
      fluorescence signifying the consumption of the study capsules. The patient will consume
      approximately 100 mg of riboflavin daily.

      The goal of compliance enhancement therapy is to achieve high quality supportive treatment as
      well as consistency between treatment groups. Treatment will be delivered in 9 individual
      sessions over 9 weeks. Sessions will last approximately 30 minutes and will be structured,
      focused on setting abstinence from benzodiazepine use as a goal, patient compliance, and
      current functioning. The therapist will promote a positive supportive therapeutic
      relationship with the treatment goal of encouraging abstinence from benzodiazepines and
      adherence to study visits and medication.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Benzodiazepine; Gabapentin; Methadone