Provigil (modafinil) plus cognitive behavioral therapy for methamphetamine use in HIV+ gay men: a pilot study.
OBJECTIVE
To evaluate the efficacy of modafinil combined with cognitive behavioral therapy (CBT) for treatment of methamphetamine (MA) dependence among HIV+ gay men.


METHODS
In a single blind trial, modafinil was administered for 12 weeks, followed by a 4-week placebo phase. CBT was conducted for 18 sessions over the 16-week study. Primary outcome measures were self-reported use of days per week plus urine toxicology assays. Additional measures included the Beck Depression Inventory, Cravings Scale, and O/C Crystal Use Scale. Response was defined as > 50% decline in days used per week. Thirteen patients were enrolled over an 18-month period.


RESULTS
Ten patients (77%) completed the trial, although two discontinued modafinil due to side effects. Six of the ten study completers reduced their MA use by > 50%.


CONCLUSIONS
These preliminary results suggest good retention using combined medication and psychotherapy, and support further examination of modafinil and CBT in double-blind placebo controlled trials.
McElhiney
Martin C
MC
Therapeutics, New York State Psychiatric Institute, New York, New York, USA. mcelhin@pi.cpmc.columbia.edu
Rabkin
Judith G
JG
Rabkin
Richard
R
Nunes
Edward V
EV
D000328:Adult; D001521:Behavior Therapy; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D015658:HIV Infections / Q000150:complications*; D006716:Homosexuality; D006801:Humans; D008297:Male; D008694:Methamphetamine / Q000009:adverse effects*; D000077408:Modafinil; D009519:New York City; D010865:Pilot Projects; D010919:Placebos; D016037:Single-Blind Method; D019966:Substance-Related Disorders / Q000150:complications / Q000188:drug therapy / Q000523:psychology / Q000534:rehabilitation*
D001559:Benzhydryl Compounds; D010919:Placebos; D008694:Methamphetamine; D000077408:Modafinil