Trial Outcomes & Findings for Modafinil for Smoked Cocaine Self-Administration (NCT NCT01778010)

NCT ID: NCT01778010

Last Updated: 2018-01-09

Results Overview

The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: 48 days
• Results posted on: 2018-01-09

Participant Flow

Participant milestones

Measure	Modafinil + Cocaine During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg).
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Modafinil + Cocaine During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg).
Overall Study Withdrawal by Subject	2
Overall Study abnormal ECG before meds	1
Overall Study Arrested	1
Overall Study rash while on placebo	1

Baseline Characteristics

Modafinil for Smoked Cocaine Self-Administration

Baseline characteristics by cohort

Measure	Modafinil + Cocaine n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 days

Population: Eight patients contributed to each condition, in a within-subjects manner.

The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

Outcome measures

Measure	Modafinil 0mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Cocaine Self-administration	0 Number of doses purchased Standard Error 0	0 Number of doses purchased Standard Error 0	0 Number of doses purchased Standard Error 0	2.2 Number of doses purchased Standard Error 0.3	1.5 Number of doses purchased Standard Error 0.3	2.1 Number of doses purchased Standard Error 0.1	4.1 Number of doses purchased Standard Error 0.2	2.5 Number of doses purchased Standard Error 0.3	2.6 Number of doses purchased Standard Error 0.3	4.5 Number of doses purchased Standard Error 0.1	3.5 Number of doses purchased Standard Error 0.3	3 Number of doses purchased Standard Error 0.3

SECONDARY outcome

Timeframe: 48 days

Population: Eight subjects participants in each condition in a within-subjects fashion.

Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:

1. "the choice was of high quality"

2. "the choice was potent"

3. "I liked the choice" Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome.

Outcome measures

Measure	Modafinil 0mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Drug Quality Cluster	2 units on a scale Standard Error 0.5	2 units on a scale Standard Error 0.5	2 units on a scale Standard Error 0.5	30 units on a scale Standard Error 5	28 units on a scale Standard Error 4	29 units on a scale Standard Error 3	44 units on a scale Standard Error 4	35 units on a scale Standard Error 4	35 units on a scale Standard Error 2	60 units on a scale Standard Error 3	55 units on a scale Standard Error 4	55 units on a scale Standard Error 4

SECONDARY outcome

Timeframe: 48 days

Population: Eight patients participated in each condition in a within-subjects fashion.

Values for heart rate as a function of cocaine dose and modafinil maintenance condition.

Outcome measures

Measure	Modafinil 0mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 0mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 12mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 25mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 0mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 200mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).	Modafinil 400mg + Cocaine 50mg n=8 Participants During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Heart Rate	88 BPM Standard Error 2	86 BPM Standard Error 2	91 BPM Standard Error 2	102 BPM Standard Error 3	101 BPM Standard Error 2.5	97 BPM Standard Error 3	130.5 BPM Standard Error 2	110 BPM Standard Error 3	115 BPM Standard Error 2.5	141 BPM Standard Error 2	125 BPM Standard Error 4	122 BPM Standard Error 2

Adverse Events

Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Haney, Ph.D.

New York State Psychiatric Institute at Columbia University Medical Center

Phone: 646-774-6153

Email: meg.haney@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place