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. 2018 Mar 15;2018(3):CD011481. doi: 10.1002/14651858.CD011481.pub2

Mariani 2016.

Methods Study design: Randomised controlled trial
Study grouping: Parallel group
Blinding: Double
Duration: 8 weeks
Single‐centre
Participants Baseline characteristics
Gabapentin
  • Age, mean (SD): 40

  • Male, N (%): 6 (75)


Placebo
  • Age, mean (SD): 37

  • Male, N (%): 8 (73)


Inclusion criteria: Meeting DSM‐IV criteria for current benzodiazepine abuse or dependence and opioid dependence, and being treated for opioid dependence with methadone, 18 to 65 years of age
Exclusion criteria: (1) Any Axis I psychiatric disorder as defined by DSM‐IV‐TR that was unstable or would be disrupted by study medication or by an effort to discontinue benzodiazepines; (2) Acute physiological withdrawal or a history of seizures during alcohol or sedative‐hypnotic withdrawal; (3) Individuals with cocaine dependence as their primary substance use disorder diagnosis; (4) Individuals with unstable physical disorders or impaired kidney function; (5) 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; (6) Anticonvulsants prescribed for pain syndromes; (7) Known sensitivity to gabapentin; (8) Individuals who had exhibited suicidal or homicidal behaviour within the past 2 years or had current active suicidal ideation; (9) Individuals physiologically dependent on any other drugs (excluding nicotine, caffeine, methadone); (10) Individuals currently prescribed gabapentin; and (11) Individuals requiring pharmacological detoxification from benzodiazepines in the past year and are unlikely to be able to tolerate taper off of benzodiazepines
Pretreament differences: None reported.
Interventions Intervention characteristics
  1. Abrupt benzodiazepine cessation + gabapentin 1200 mg 3 times daily(N = 8)

  2. Abrupt benzodiazepine cessation (control group)(N = 11)

Outcomes Benzodiazepine mean dose
Identification Sponsorship source: Funding for this work was provided by National Institute on Drug Abuse grants K23‐ DA021209 (Mariani), P50‐DA09236 (Kleber), K24‐ DA022412 (Nunes), and K24 029647 (Levin).
Country: USA
Setting: Methadone maintenance outpatients
Declarations of interest: None
Authors name: John J Mariani
Institution: Division on Substance Abuse, New York State Psychiatric Institute, New York, NY, USA
Email: jm2330@columbia.edu
Address: New York State Psychiatric Institute, Division on Substance Abuse, 1051 Riverside Drive, Unit 66, New York, NY 10032, USA
Notes Data not reported sufficiently, not possible to extract results relevant to this review. The author has not responded to our queries.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Randomisation method not described.
Allocation concealment (selection bias) Unclear risk Comment: Not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: All capsules were over‐capsulated with riboflavin to ensure compliance.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: Not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: Only 50% were retained in the study.
Selective reporting (reporting bias) Low risk Comment: Selective outcome reporting not evident.
Other bias Low risk Comment: No other apparent source of bias