Trial Outcomes & Findings for Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving (NCT NCT01929343)

Results Overview

7 days after lidocaine/saline administration, cocaine craving will be measured during the administration of relaxation or craving script. Craving intensity will be measured by the subjective intensity of craving as reported by the participant. Measured via a visual analog scale based on 4 (out of 10) questions from the Cocaine Craving Questionnaire (1-strongly disagree to 7- strongly agree). Highest total score possible 28, lowest score possible is 4. If the score is low in the lidocaine group and high in the saline group, it would mean that lidocaine has successfully decreased the craving response relative to saline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

craving measured immediately following reading of the script.

Results posted on

2020-12-31

Participant Flow

84 participants were consented to participate in the study. 48 were withdrawn as they did not meet inclusion/exclusion criteria (insufficient use of cocaine, medical concerns, positive drug screens or psychiatric disorders) upon further screening and evaluation. Thus, we are reporting on 36 participants.

Participant milestones

Participant milestones
Measure	Lidocaine Following Cue-induced Craving Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Overall Study STARTED	12	9	12
Overall Study COMPLETED	11	7	12
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Following Cue-induced Craving Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Overall Study Physician Decision	0	2	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Following Cue-induced Craving n=12 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=9 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	33 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants

PRIMARY outcome

Timeframe: craving measured immediately following reading of the script.

Population: 3 participants were lost to follow-up and hence we could analyze only the available data.

7 days after lidocaine/saline administration, cocaine craving will be measured during the administration of relaxation or craving script. Craving intensity will be measured by the subjective intensity of craving as reported by the participant. Measured via a visual analog scale based on 4 (out of 10) questions from the Cocaine Craving Questionnaire (1-strongly disagree to 7- strongly agree). Highest total score possible 28, lowest score possible is 4. If the score is low in the lidocaine group and high in the saline group, it would mean that lidocaine has successfully decreased the craving response relative to saline.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=11 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Cue-induced Craving After Lidocaine/Saline Administration.	31.7 units on a scale Standard Deviation 12.6	17.3 units on a scale Standard Deviation 9.5	22.7 units on a scale Standard Deviation 11.9

PRIMARY outcome

Timeframe: 120 seconds, during reading of the script.

Population: 3 participants were lost to follow-up and hence we could analyze only the available data.

7 days after lidocaine/saline administration, heart rate will be measured during the administration of a relaxation or craving script. Heart rate will be measured in beats per minute.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=11 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Physiological Responses as Measured by Heart Rate After Lidocaine/Saline Administration.	67.4 beats per minute Standard Deviation 27.4	73.0 beats per minute Standard Deviation 19.4	77.5 beats per minute Standard Deviation 16.6

PRIMARY outcome

Timeframe: BP will measured during the two minutes of script reading.

Population: The data was not collected and hence was not analyzed.

7 days after lidocaine/saline administration, blood pressure (BP) response will be assessed during relaxation or craving script. Blood pressure will be measured by mmHg.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 minutes during script reading.

Population: 3 participants were lost to follow-up and hence we could analyze only the available data.

7 days after lidocaine/saline administration, GSR will be measured during the reading of the relaxation or saline script. It is predicted that higher GSR would be associated with higher cocaine craving and lower GSR will be associated with lower cocaine craving.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=11 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Physiological Responses as Measured by Galvanic Skin Response (GSR) After Lidocaine/Saline Administration.	19.1 EDA Amplitute (uS) Standard Deviation 4.5	20.1 EDA Amplitute (uS) Standard Deviation 0.2	20.4 EDA Amplitute (uS) Standard Deviation 0.7

PRIMARY outcome

Timeframe: 2 minutes during administration of script.

Electromyography (frontal) will be measured during the administration of the relaxation or craving script seven days after infusion. EMG is assessed by uV (microvolts). Higher scores reflect greater amounts of EMG activity, lower scores reflect lower amounts of EMG activity. It was expected that EMG would be positively associated with cocaine craving.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=10 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Physiological Responses as Measured by EMG (Electromyography) After Lidocaine/Saline Administration.	21.6 uV Standard Deviation 44.5	28.1 uV Standard Deviation 57.8	5.9 uV Standard Deviation 2.1

SECONDARY outcome

Timeframe: cocaine use will be measure during the 4 weeks following infusion

cocaine use will be measured by urine drug screen and participant self-report three times weekly after lidocaine/saline administration. Cocaine use will be assessed as positive (1) or negative (0) using urine drug screen for cocaine and/or by participant self-report of cocaine use.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=10 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=11 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Cocaine Use	3.8 days of cocaine used/week Standard Deviation 1.8	2.7 days of cocaine used/week Standard Deviation 0.8	3.0 days of cocaine used/week Standard Deviation 0.0

SECONDARY outcome

Timeframe: cocaine craving will be measure during the 4 weeks following infusion

Population: Only available data were analyzed. Some participants were lost to follow-up.

basal measures of cocaine craving will be measured by Cocaine Craving Questionnaire (CCQ) times weekly after lidocaine/saline administration. The higher the score the more craving and lower the score the less craving. The CCQ has 10 items, each item scored 1-7. Maximum score is 70, minimum score is 7.

Outcome measures

Outcome measures
Measure	Lidocaine Following Cue-induced Craving n=11 Participants Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following cue-induced craving: as described in Arm Description	Lidocaine Following Neutral Stimulus n=7 Participants Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours. lidocaine following neutral stimulus: as described in Arm Description	Saline n=12 Participants Saline will be administered at same volume of lidocaine in active arms. saline: as described in Arm Description
Cocaine Craving	32.3 units on a scale Standard Deviation 18.5	15.8 units on a scale Standard Deviation 4.8	20.9 units on a scale Standard Deviation 15.6

Adverse Events

Lidocaine Following Cue-induced Craving

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine Following Neutral Stimulus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

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

Josh Becker

UT Southwestern Medical Center

Phone: 2146485277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place