Opioid Dependence Clinical Trial
Official title:
A Randomized Controlled Pilot Trial of Gabapentin for the Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
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.
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.
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