Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/3/2018 |
| Start Date: | January 2007 |
| End Date: | January 2011 |
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
