Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients

NCT00420771 | Completed Phase 2 Results

• 2 other identifiers: 4906/#5998RK23DA021209
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benzodiazepine Dependence; Opioid Dependence

Keywords

Benzodiazepine; Gabapentin; Methadone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gabapentin

EXPERIMENTAL

gabapentin treatment 1200 mg three times daily

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Placebo condition received pills identical in appearance to experimental arm.

Drug: Placebo

Interventions

Gabapentin DRUG

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.

Also known as: Neurontin

Gabapentin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Bridge Plaza Treatment and Rehabilitation Clinic

Long Island City, New York, 11101, United States

Location

Related Publications (1)

• Mariani JJ, Malcolm RJ, Mamczur AK, Choi JC, Brady R, Nunes E, Levin FR. Pilot trial of gabapentin for the treatment of benzodiazepine abuse or dependence in methadone maintenance patients. Am J Drug Alcohol Abuse. 2016 May;42(3):333-40. doi: 10.3109/00952990.2015.1125493. Epub 2016 Mar 10.

  PMID: 26962719 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

An adequately powered double-blind trial is required to further evaluate the utility of gabapentin in treating benzodiazepine use disorder. Recruitment from more than one program is likely to be required to reach an adequate sample size.

Results Point of Contact

• Title: John J. Mariani, MD
• Organization: NYSPI

jm2330@columbia.edu

212-543-5987

Study Officials

• John J Mariani, M.D

  Columbia University/New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 24, 2019
• Results First Posted: July 12, 2018

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)