Opioid Dependence Clinical Trial
Official title:
A Randomized Controlled Pilot Trial of Gabapentin for the Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Verified date | April 2019 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bridge Plaza Treatment and Rehabilitation Clinic | Long Island City | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back | Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back | data collected during 8 weeks of trial or length of participation |
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