Background: Cocaine abuse occurs in 40% to 60% of patients entering opioid
maintenance treatment, and effective pharmacotherapies are needed for this
combined dependence.
Methods: This 13-week, randomized, double-blind, placebo-controlled trial e
valuated the efficacy of desipramine hydrochloride (0 or 150 mg/d) plus bup
renorphine hydrochloride (12 mg/d) or methadone hydrochloride (65 mg/d) in
180 opioid-dependent cocaine abusers (124 men, 56 women). Supervised urine
samples were obtained thrice weekly, and self-reported cocaine and heroin u
se was reported once weekly. Desipramine plasma levels were determined at w
eeks 4 and 10.
Results: In men, opioid abstinence was increased more rapidly over time whe
n treated with methadone than with buprenorphine, whereas cocaine abstinenc
e was increased more with buprenorphine than with methadone. In women, opio
id abstinence was increased the least rap-idly when treated with buprenorph
ine plus placebo, while cocaine abstinence was increased more rapidly over
time when created with methadone than with buprenorphine. Regardless of sex
or opioid medication, desipramine increased opioid and cocaine abstinence
more rapidly over time than placebo. Self-reported opioid use confirmed the
se findings. Desipramine plasma levels were higher in women than in men, pa
rticularly those on buprenorphine maintenance, Higher desipramine plasma le
vels were associated with greater opioid, but not cocaine, abstinence.
Conclusions: Desipramine may be a useful adjunctive medication in facilitat
ing opioid and cocaine abstinence in opioid-maintained patients. The effica
cy of opioid medications to treat opioid or cocaine dependence may differ b
y sex. These findings highlight the importance of including ses as a factor
when examining treatment outcome in these types of trials.