Benzodiazepine DependencePhase 2NCT01893632
Gabapentin Treatment of Benzodiazepine Dependence
A Phase 2 study testing gabapentin in people with Benzodiazepine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Benzodiazepine dependence is a growing public health problem for which very few evidenced-based treatment approaches are available. Approximately 683,000 individuals met past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence greater than heroin or methamphetamine dependence. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Benzodiazepine Dependence
- What is being tested?
- gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 1 Apr 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets DSM-IV-TR criteria for BZD dependence
- Using BZDs a minimum of 5 days per week over the past 28 days
- Between the ages of 18 and 60
- Able to provide informed consent
Who cannot join
- Any current DSM-IV-TR Axis I psychiatric disorder, other than BZD dependence, that might require intervention over the course of the study, including schizophrenia, bipolar disorder, major depressive disorder or panic disorder.
- Receiving psychotropic medication other than BZDs
- Evidence of physiological BZD withdrawal (pulse > 100; blood pressure > 140/90)
- History of BZD withdrawal seizures or withdrawal delirium
- History of allergic reaction to GBP
- Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods
- Unstable physical disorders which might make participation hazardous medical history
- Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine history; dependence
Trial locations and contacts
1 site in 1 country.
About this study
Benzodiazepine dependence is a growing public health problem for which very few evidenced-based treatment approaches are available. Approximately 683,000 individuals met past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence greater than heroin or methamphetamine dependence. The most commonly prescribed sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic tolerance in the GABA neurotransmitter system and individuals with physiological dependence find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms, which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based treatment approaches have been primarily directed at therapeutic users of benzodiazepines who do not meet criteria for a substance use disorder, with a general consensus that the gradual taper of benzodiazepines over a period of several months is the optimal approach. However, patients with benzodiazepine dependence are typically referred for inpatient detoxification treatment, which rapidly tapers patients off benzodiazepines. Protracted withdrawal symptoms frequently persist after discharge, predisposing patients to relapse. More effective pharmacotherapeutic strategies are needed for the treatment of benzodiazepine dependence in the outpatient setting.
Read the detailed description
Gabapentin has proven to be a safe and well-tolerated medication with a low abuse liability, thereby making it ideal for use in the outpatient setting.
The proposed Exploratory Development research project is a double-blind randomized controlled clinical trial comparing the efficacy of gabapentin to placebo for the outpatient treatment of benzodiazepine dependence. The goal of this project is to study the effects of gabapentin on the participants' benzodiazepine use in a facilitated taper-to-abstinence model, where participants will be actively using benzodiazepines at study entry, gabapentin treatment will be introduced, and participants will be counseled to gradually discontinue benzodiazepine use over the study period while gabapentin treatment is maintained. A modified version of Medical Management will be used to facilitate compliance with study medication and other study procedures, and includes clinical instruction for gradually reducing benzodiazepine use 25% per week. Benzodiazepines are not prescribed in the proposed study; participants continue to obtain benzodiazepines from their own prescribed or nonprescribed sources.
- Conditions
- Benzodiazepine Dependence
- Being tested
- gabapentin, Placebo
- Keywords
- Benzodiazepines, clonazepam, alprazolam, Klonopin, Xanax, diazepam, Valium, lorazepam, Ativan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
Also called Neurontin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary. Receives: Drug: gabapentin |
| Placebo | Placebo comparator | Capsules filled with riboflavin. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence From Benzodiazepine Use
Achievement of two weeks abstinence from benzodiazepine use at end of trial
Measured: last two weeks of 12 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Why it stopped: Insufficient recruitment, funding terminated from sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benzodiazepine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Mariani MD, New York State Psychiatric Institute
- Investigators
- John J. Mariani, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893632
- Sponsor's protocol ID
- 6740
- Status last verified
- Apr 2019
- First submitted
- 29 Jun 2013
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No