Mariani 2016.
Methods |
Study design: Randomised controlled trial Study grouping: Parallel group Blinding: Double Duration: 8 weeks Single‐centre |
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Participants |
Baseline characteristics Gabapentin
Placebo
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. |
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Interventions |
Intervention characteristics
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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 |
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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 |