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Chunk #24 — RESULTS — Safety, Tolerability, and Concomitant Therapy

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Gabapentin treatment for alcohol dependence: a randomized clinical trial.
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Gabapentin was well-tolerated with no deaths and no serious drug-related adverse events. Nine subjects discontinued the study due to adverse events. Of these, five were rated as drug-related by blinded study physicians: two complaints of headache (900mg), two complaints of fatigue (one 900mg and one 1800mg) and one complaint of euphoria and speediness (placebo). No differences were found among groups in type of adverse events (eTable 2), with ≥10% of the sample complaining of fatigue (23%), insomnia (18%), and headache (14%). Groups also were similar in the number (1.98 [2.14], p=0.53) and severity (1.72 [1.14]; 1=mild, 2=moderate, p=0.63) of adverse events reported. Groups did not differ in body weight, vital signs, or on measures from urinalysis and blood chemistry testing that took place over the course of treatment. No evidence was found of drug diversion or substitution; of the 1242 urine drug screens collected in our study 27 (2%) tested positive for other drugs of abuse, primarily marijuana and prescription drugs. Five subjects attended individual therapy and nine attended Alcoholics Anonymous (AA) meetings during the course of the study. Attendance