Trial Outcomes & Findings for Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use (NCT NCT02927236)

NCT ID: NCT02927236

Last Updated: 2025-02-25

Results Overview

Number of cocaine dependent participants who tolerated the intermittent Theta-Burst Stimulation (iTBS) treatment. Participants in the pilot group had a maximum of 2 weeks and participants in the EFS group had a maximum of three weeks to complete the 10 days of treatment.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Up to 10 days of treatment
• Results posted on: 2025-02-25

Participant Flow

Pilot Phase: participants complete a characterization phase prior to the treatment phase and do not proceed to the treatment phase unless they tolerate a brief trial of intermittent Theta-Burst Stimulation (iTBS) Expanded Feasibility Study (EFS) Phase: participants complete a characterization phase and do not proceed to the treatment phase unless they tolerate a brief trial of iTBS and score in the unimpaired range on Trails B, used to assess for cognitive impairment after receiving iTBS

Participant milestones

Measure	Pilot Group Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Cocaine - Sham Group Participants with cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day with at least five days between the active and sham treatment.
Characterization Phase STARTED	19	4	3	19
Characterization Phase COMPLETED	18	1	3	13
Characterization Phase NOT COMPLETED	1	3	0	6
Treatment Phase STARTED	14	1	2	12
Treatment Phase COMPLETED	9	1	1	10
Treatment Phase NOT COMPLETED	5	0	1	2
Follow-up Phase STARTED	9	1	2	10
Follow-up Phase COMPLETED	8	1	1	10
Follow-up Phase NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Measure	Pilot Group Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Cocaine - Sham Group Participants with cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day with at least five days between the active and sham treatment.
Characterization Phase Physician Decision	0	3	0	2
Characterization Phase Lost to Follow-up	0	0	0	3
Characterization Phase Withdrawal by Subject	1	0	0	1
Treatment Phase Adverse Event	1	0	1	1
Treatment Phase Protocol Violation	3	0	0	1
Treatment Phase Lost to Follow-up	1	0	0	0
Follow-up Phase Lost to Follow-up	1	0	1	0

Baseline Characteristics

Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use

Baseline characteristics by cohort

Measure	Pilot Group n=19 Participants Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=4 Participants Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Cocaine - Sham Group n=3 Participants Participants with cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control n=19 Participants Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double blind experiment in one day with at least five days between the active and sham treatment.	Total n=45 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants	45 Participants n=21 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	0 Participants n=21 Participants
Age, Continuous	47.5 years STANDARD_DEVIATION 8.6 • n=5 Participants	50.25 years STANDARD_DEVIATION 11.15 • n=7 Participants	42 years STANDARD_DEVIATION 8.89 • n=5 Participants	35.7 years STANDARD_DEVIATION 9.23 • n=4 Participants	42.26 years STANDARD_DEVIATION 10.68 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	19 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	19 participants n=4 Participants	45 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 10 days of treatment

Population: Per protocol document, analysis applies to only participants who had cocaine dependence.

Number of cocaine dependent participants who tolerated the intermittent Theta-Burst Stimulation (iTBS) treatment. Participants in the pilot group had a maximum of 2 weeks and participants in the EFS group had a maximum of three weeks to complete the 10 days of treatment.

Outcome measures

Measure	Pilot Group n=14 Participants Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=1 Participants Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.	Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Healthy participants without cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.
Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation Sessions	9 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: pre/post treatment day 1.

Population: The analysis was between-subjects for cocaine dependent participants and within-subjects for healthy participants. No imaging data was collected for the Pilot arm so no results are reported.

Participants received resting brain fMRI scan followed by three iTBS sessions then a second brain fMRI scan. Analysis was done to determine if iTBS alters brain networks and calculated as the difference between global efficiency (GE) before and after the first day of iTBS (pre-post). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) * sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.

Outcome measures

Measure	Pilot Group n=1 Participants Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=2 Participants Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control - Active Treatment n=11 Participants Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.	Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment n=11 Participants Healthy participants without cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.
Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect)	-0.03716097 unitless Standard Deviation 0	0.004610517 unitless Standard Deviation 0.003557275	-.01535 unitless Standard Deviation 0.032982662	-0.008708172 unitless Standard Deviation 0.021423157

PRIMARY outcome

Timeframe: Baseline (pre-treatment) minus two weeks post treatment

Population: Analysis included only cocaine dependent participants in the Expanded Feasibility Study (EFS) arms who completed the baseline and follow up fMRI brain scans. Chronic effects of iTBS were not measured in the Pilot or in EFS healthy participants.

Participants received baseline resting brain fMRI scan on day one and had a repeat brain fMRI two weeks after iTBS treatment course. Analysis was done to determine change in brain network with chronic treatment in cocaine dependent participants and calculated as the difference between global efficiency (GE) from baseline to post treatment (2 weeks after end of treatment). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) * sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.

Outcome measures

Measure	Pilot Group n=1 Participants Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=2 Participants Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.	Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Healthy participants without cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.
Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect)	-0.009259302 unitless Standard Deviation 0	-0.021988865 unitless Standard Deviation 0.009881832	—	—

PRIMARY outcome

Timeframe: Baseline (pre-treatment)

Population: Analysis included all cocaine dependent participants (combined as one group as no intermittent Theta-Burst Stimulation (iTBS) sessions had been administered at this timepoint) and healthy control participants who had a baseline brain fMRI scan. No baseline scan was done on Pilot participants.

The brain global efficiency for cocaine dependent participants and healthy control participants at baseline (pre-treatment), prior to intermittent Theta-Burst Stimulation Treatment (iTBS). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shortest pathway between each pair of nodes. The final value is 1/N(N-1) * sum 1/shortest pathway between each pair of the N nodes. It ranges between 0 and 1 with higher values indicating greater efficiency.

Outcome measures

Measure	Pilot Group n=6 Participants Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=15 Participants Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.	Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Healthy participants without cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in one day.
Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS)	0.370168044 unitless Standard Deviation 0.070814395	0.328063781 unitless Standard Deviation 0.035358035	—	—

Adverse Events

Pilot Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Expanded Feasibility Study (EFS): Cocaine - Active Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Expanded Feasibility Study (EFS): Cocaine - Sham Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pilot Group n=19 participants at risk Participants with cocaine dependence receive open label three daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions for up to 10 days.	Expanded Feasibility Study (EFS): Cocaine - Active Group n=4 participants at risk Participants with cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Cocaine - Sham Group n=3 participants at risk Participants with cocaine dependence receive three sham daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment for up to 10 days and fMRI brain scans.	Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Intervention n=19 participants at risk Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day with at least five days between the active and sham treatment.	Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Intervention n=19 participants at risk Healthy participants without cocaine dependence receive three active daily intermittent Theta-Burst Stimulation (iTBS) sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day and three sham daily iTBS sessions with an inter-administration interval of at least 60-minutes between sessions in a double-blind experiment in one day with at least five days between the active and sham treatment.
Nervous system disorders headache	36.8% 7/19 • Number of events 13 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	33.3% 1/3 • Number of events 3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	5.3% 1/19 • Number of events 2 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	10.5% 2/19 • Number of events 2 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Eye disorders eye pain	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	33.3% 1/3 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Nervous system disorders Nervous system- other	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Renal and urinary disorders Urine discoloration	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	33.3% 1/3 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Skin and subcutaneous tissue disorders eczema	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	33.3% 1/3 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Psychiatric disorders tactile hallucinations	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Skin and subcutaneous tissue disorders scalp pain	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Musculoskeletal and connective tissue disorders back pain	10.5% 2/19 • Number of events 3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Skin and subcutaneous tissue disorders hang nail bleeding	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Musculoskeletal and connective tissue disorders arthritis	5.3% 1/19 • Number of events 2 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Psychiatric disorders memory loss	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Musculoskeletal and connective tissue disorders muscle aches	10.5% 2/19 • Number of events 2 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Gastrointestinal disorders nausea and vomiting	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Gastrointestinal disorders tooth and ear pain	10.5% 2/19 • Number of events 2 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/3 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.
Nervous system disorders tremor	5.3% 1/19 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/4 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	33.3% 1/3 • Number of events 1 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.	0.00% 0/19 • Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks.

Additional Information

Yihong Yang, PhD

National Institute on Drug Abuse (NIDA)

Phone: 443-740-2648

Email: yihong.yang@nih.gov

Results disclosure agreements

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