Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 100-107 |
| Number of pages | 8 |
| Journal | Drug and alcohol dependence |
| Volume | 136 |
| Issue number | 1 |
| DOIs | |
| State | Published - Mar 1 2014 |
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Keywords
- Cocaine cessation
- Contingency management
- Levodopa
- Modafinil
- Naltrexone
- Relapse prevention
Cite this
A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention : Modafinil, levodopa-carbidopa, naltrexone. / Schmitz, Joy M.; Green, Charles E.; Stotts, Angela L.; Lindsay, Jan A.; Rathnayaka, Nuvan S.; Grabowski, John; Moeller, F. Gerard.
In: Drug and alcohol dependence, Vol. 136, No. 1, 01.03.2014, p. 100-107.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention
T2 - Modafinil, levodopa-carbidopa, naltrexone
AU - Schmitz, Joy M.
AU - Green, Charles E.
AU - Stotts, Angela L.
AU - Lindsay, Jan A.
AU - Rathnayaka, Nuvan S.
AU - Grabowski, John
AU - Moeller, F. Gerard
PY - 2014/3/1
Y1 - 2014/3/1
N2 - 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.
AB - 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.
KW - Cocaine cessation
KW - Contingency management
KW - Levodopa
KW - Modafinil
KW - Naltrexone
KW - Relapse prevention
UR - http://www.scopus.com/inward/record.url?scp=84893716534&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84893716534&partnerID=8YFLogxK
U2 - 10.1016/j.drugalcdep.2013.12.015
DO - 10.1016/j.drugalcdep.2013.12.015
M3 - Article
C2 - 24424425
AN - SCOPUS:84893716534
VL - 136
SP - 100
EP - 107
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
SN - 0376-8716
IS - 1
ER -