Journal
DRUG AND ALCOHOL DEPENDENCE
Volume 136, Issue -, Pages 100-107Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.drugalcdep.2013.12.015
Keywords
Contingency management; Levodopa; Modafinil; Naltrexone; Cocaine cessation; Relapse prevention
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Funding
- National Institute on Drug Abuse (NIDA) Medications Development Center [P50-DA-9262]
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Background: Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels, obscuring possible medication efficacy. Testing the feasibility of using a prerandomization, abstinence-induction protocol, we screened three candidate medications to explore treatment response in patients who did, or did not, achieve abstinence during an extended baseline phase. Method: Eligible treatment-seeking, cocaine-dependent subjects entered a 4-week baseline period (Phase I) with high-value abstinence contingent vouchers and two motivational interviewing sessions, followed by a 12-week medication trial (Phase II) with random assignment stratified on Phase I abstinence status to (1) modafinil (400 mg/d), (2) levodopa/carbidopa (800/200 mg/d), (3) naltrexone (50 mg/d), or (4) placebo. Treatment consisted of thrice-weekly clinic visits for urine benzoylecgonine testing and weekly cognitive behavioral therapy with contingency management targeting medication compliance. Results: Of the 118 subjects enrolled, 81 (80%) completed Phase I, with 33 (41%) achieving abstinence, defined a priori as 6 consecutive cocaine-negative urines. Tests of the interaction of each medication (active versus placebo) by baseline status (abstinent versus nonabstinent) permitted moderator effect analysis. Overall, baseline abstinence predicted better outcome. Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status, with both medications producing benefit in nonabstinent but not baseline-abstinent subjects. There was no evidence of a moderator effect for modafinil. Conclusions: The two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications. (C) 2014 Elsevier Ireland Ltd. All rights reserved.
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