Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Benzodiazepine Dependence, Opioid Dependence

In brief

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.

Key facts

Study ID: NCT00420771
Run by: New York State Psychiatric Institute
People needed: 19
Starts: 2007-01-01
Expected to finish: 2011-01-01
Last updated by the study team: 2019-04-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Bridge Plaza Treatment and Rehabilitation Clinic — Long Island City, New York, United States

Full record on ClinicalTrials.gov

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