Trial Outcomes & Findings for Medications for Stopping Cocaine Dependence and Preventing Relapse (NCT NCT00218023)
NCT ID: NCT00218023
Last Updated: 2017-06-09
Results Overview
Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
3 times per week (Monday, Wednesday, and Friday) for 12 weeks
Results posted on
2017-06-09
Participant Flow
101 subjects were enrolled and began phase 1 (in phase 1, all enrolled subjects received the same intervention, motivational interviewing, which is described in the Interventions section). 81 completed phase 1, and 81 started phase 2, as described in the Period below. Subjects were assigned to the 4 arms at phase 2.
Participant milestones
| Measure |
Modafinil Plus MI, CM, and CBT
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Levodopa/Carbidopa Plus MI, CM, and CBT
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Naltrexone HCl Plus MI, CM, and CBT
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Placebo Plus MI, CM, and CBT
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
16
|
18
|
|
Overall Study
Received Drug or Placebo in Phase II
|
18
|
24
|
15
|
18
|
|
Overall Study
COMPLETED
|
9
|
10
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medications for Stopping Cocaine Dependence and Preventing Relapse
Baseline characteristics by cohort
| Measure |
Modafinil Plus MI, CM, and CBT
n=22 Participants
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Levodopa/Carbidopa Plus MI, CM, and CBT
n=25 Participants
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Naltrexone HCl Plus MI, CM, and CBT
n=16 Participants
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Placebo Plus MI, CM, and CBT
n=18 Participants
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.64 years
STANDARD_DEVIATION 5.71 • n=5 Participants
|
40.66 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
42.08 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
42.29 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
42.16 years
STANDARD_DEVIATION 8.67 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
16 participants
n=5 Participants
|
18 participants
n=4 Participants
|
81 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 times per week (Monday, Wednesday, and Friday) for 12 weeksCocaine use was determined by assessing for the presence of benzoylecgonine in urine.
Outcome measures
| Measure |
Modafinil Plus MI, CM, and CBT
n=8 Participants
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Levodopa/Carbidopa Plus MI, CM, and CBT
n=8 Participants
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Naltrexone HCl Plus MI, CM, and CBT
n=9 Participants
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Placebo Plus MI, CM, and CBT
n=10 Participants
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
|---|---|---|---|---|
|
Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline
|
31 Mean % of cocaine-positive urines
Standard Error 0.238
|
28 Mean % of cocaine-positive urines
Standard Error 0.20
|
47 Mean % of cocaine-positive urines
Standard Error 0.261
|
35 Mean % of cocaine-positive urines
Standard Error 0.186
|
PRIMARY outcome
Timeframe: 3 times per week (Monday, Wednesday, and Friday) for 12 weeksCocaine use was determined by assessing for the presence of benzoylecgonine in urine.
Outcome measures
| Measure |
Modafinil Plus MI, CM, and CBT
n=14 Participants
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Levodopa/Carbidopa Plus MI, CM, and CBT
n=17 Participants
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Naltrexone HCl Plus MI, CM, and CBT
n=7 Participants
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Placebo Plus MI, CM, and CBT
n=8 Participants
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
|---|---|---|---|---|
|
Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline
|
88 Mean % of cocaine-positive urines
Standard Error 0.029
|
49 Mean % of cocaine-positive urines
Standard Error 0.254
|
62 Mean % of cocaine-positive urines
Standard Error 0.219
|
91 Mean % of cocaine-positive urines
Standard Error 0.016
|
Adverse Events
Modafinil Plus MI, CM, and CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Levodopa/Carbidopa Plus MI, CM, and CBT
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone HCl Plus MI, CM, and CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Plus MI, CM, and CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modafinil Plus MI, CM, and CBT
n=22 participants at risk
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Levodopa/Carbidopa Plus MI, CM, and CBT
n=25 participants at risk
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Naltrexone HCl Plus MI, CM, and CBT
n=16 participants at risk
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
Placebo Plus MI, CM, and CBT
n=18 participants at risk
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.
|
|---|---|---|---|---|
|
Eye disorders
eye injury (torn conjunctiva)
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
4.0%
1/25 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
Respiratory, thoracic and mediastinal disorders
respiratory infection
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
4.0%
1/25 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
Cardiac disorders
arrhythmia symptoms
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
4.0%
1/25 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
Psychiatric disorders
suicidal tendencies
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
4.0%
1/25 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
Hepatobiliary disorders
routine liver-function tests showed an increase from baseline in hepatic enzyme values
|
4.5%
1/22 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/25 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
General disorders
work-related traumatic injury to finger that required surgical repair
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/25 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
6.2%
1/16 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/18 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/22 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/25 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
0.00%
0/16 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
5.6%
1/18 • Number of events 1 • The 12 weeks during which the drugs were administered (i.e., Phase II).
|
Other adverse events
Adverse event data not reported
Additional Information
Joy M. Schmitz, PhD
The University of Texas Health Science Center at Houston
Phone: (713) 486-2867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place