Cocaine Use, UnspecifiedEarly Phase 1NCT03954938

Behavioral Effects of Drugs (Inpatient): 38

A Early Phase 1 study testing Craving Manipulation and Cocaine in people with Cocaine Use, Unspecified, run by William Stoops at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cocaine Use, Unspecified
What is being tested?: Craving Manipulation and Cocaine
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 15 May 2019to 3 Dec 2021
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Current cocaine use

Who cannot join

Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
Current or past histories of substance use disorder that are deemed by the study physicians to interfere with study completion
History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
Females not currently using effective birth control
Contraindications to cocaine

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40507

Other trials in United States

About this study

Official title: Influence of Craving Manipulation on Cocaine Self-Administration

The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for cocaine use disorder will complete an outpatient, crossover, placebo-controlled study consisting of 1 practice and 9 experimental sessions. In each experimental session, the reinforcing effects of intranasal cocaine will be determined under one of three regulation of craving conditions that simulate CBT decisional analysis (i.e., negative instruction, positive instruction or a neutral "look" condition). After sampling the dose of cocaine available in each session, subjects will complete the craving manipulation assigned to that session, they will then rate their craving and finally they will have the opportunity to earn the sampled dose in a progressive-ratio procedure. We hypothesize that focusing on the negative effects of cocaine use will decrease craving and reduce cocaine self-administration relative to the positive and "look" conditions, and that craving will be positively correlated with self-administration outcomes.

Conditions: Cocaine Use, Unspecified
Being tested: Craving Manipulation, Cocaine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Craving ManipulationBehavioural
Craving will be manipulated based on instructions about cocaine associated images shown to subjects.
CocaineDrug
The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.
PlaceboDrug
The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.

Study groups in NCT03954938
Study group	Role	What they receive
Neutral-Look	Sham comparator	Subjects will be instructed to look at cocaine associated images and respond naturally. Receives: Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo
Positive	Experimental	Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. Receives: Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo
Negative	Active comparator	Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. Receives: Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Times Cocaine Was Selected
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions.
Measured: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Secondary outcomes (1)

Cocaine Craving
Cocaine craving was assessed using a 10 point craving questionnaire that asks subjects to rate how much they are craving cocaine at that moment. The minimum craving score is 0 (i.e., no craving), the maximum craving score is 10 (i.e., highest craving).
Measured: Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 20193 Dec 2021

First posted17 May 2019
Study start15 May 2019
Primary completion3 Dec 2021
Study completion3 Dec 2021

Why it stopped: COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cocaine Use, UnspecifiedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03954938
Sponsor's protocol ID: BED In 38
Status last verified: Apr 2024
First submitted: 15 May 2019
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Craving Manipulation on Cocaine Self-Administration
ClinicalTrials.gov ID: NCT03954938
Acronym / sponsor ID: BED In 38
Conditions: Cocaine Use, Unspecified
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19
Enrolment: 5 participants (actual)
Lead sponsor: William StoopsUniversity, hospital or other
Study start: 15 May 2019 (actual)
Primary completion: 3 Dec 2021 (actual)
Study completion: 3 Dec 2021 (actual)
First posted: 17 May 2019 (actual)
Results: Posted 23 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Neutral-Look	Sham comparator	Behavioral: Craving Manipulation, Drug: Cocaine, Drug: PlaceboSubjects will be instructed to look at cocaine associated images and respond naturally.
Positive	Experimental	Behavioral: Craving Manipulation, Drug: Cocaine, Drug: PlaceboSubjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.
Negative	Active comparator	Behavioral: Craving Manipulation, Drug: Cocaine, Drug: PlaceboSubjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Current cocaine use

Key exclusion criteria (5 listed)

Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
Current or past histories of substance use disorder that are deemed by the study physicians to interfere with study completion
History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
Females not currently using effective birth control
Contraindications to cocaine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Craving ManipulationCraving will be manipulated based on instructions about cocaine associated images shown to subjects.	Behavioural	Negative, Neutral-Look, Positive
CocaineThe pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.	Drug	Negative, Neutral-Look, Positive
PlaceboThe pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.	Drug	Negative, Neutral-Look, Positive

Primary outcome

Number of Times Cocaine Was Selected
Time frame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions.

1 secondary outcome

Cocaine Craving
Time frame: Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Results and safety

Results posted to the registry on 23 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BED IN 38	5	2

Primary outcome: Number of Times Cocaine Was Selected

Time frame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.. Mean (Standard Error). Unit: Times Cocaine Selected

Measure	Neutral-Look-0 mg Cocaine n = 2	Positive-0 mg Cocaine n = 2	Negative-0 mg Cocaine n = 2	Neutral-Look-40 mg Cocaine n = 2	Positive-40 mg Cocaine n = 2	Negative-40 mg Cocaine n = 2	Neutral-Look-80 mg Cocaine n = 2	Positive-80 mg Cocaine n = 2	Negative-80 mg Cocaine n = 2
Value	0 (0)	0 (0)	0 (0)	1.5 (1.5)	1 (1)	1.5 (0.5)	1 (1)	2 (2)	2 (0)

Population analysed: Completing Subjects; Only data from completing subjects included due to within subjects design of the project.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Two weeks of study participation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Positive-0 mg Cocaine	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Positive-40 mg Cocaine	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Positive-80 mg Cocaine	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Look-0 mg Cocaine	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Look-40 mg Cocaine	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Look-80 mg Cocaine	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Negative-0 mg Cocaine	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Negative-40 mg Cocaine	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Negative-80 mg Cocaine	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed; only completing subjects' data analyzed due to within subjects design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William W Stoops, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Craving Manipulation and Cocaine in people with Cocaine Use, Unspecified, run by William Stoops at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Times Cocaine Was Selected (time frame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03954938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.