Cannabis-use DisordersEarly Phase 1NCT01511640

Behavioral Effects of Pregabalin and Cannabis

A Early Phase 1 study testing Pregabalin in people with Cannabis-use Disorders, run by Joshua A. Lile, Ph.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Cannabis-use Disorders
What is being tested?: Pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2017to 15 Mar 2020
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

regular cannabis use
good health other than cannabis use
willingness to attempt abstinence
effective form of birth control in female subjects
available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each
located in close proximity to University of Kentucky

Who cannot join

medical screening outcomes outside normal ranges or deemed clinically insignificant
medical history that would contraindicate pregabalin administration

Trial locations and contacts

1 site in 1 country.

United States1 site

Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40536-0086

Other trials in United States

About this study

Official title: Behavioral Effects of Drugs (Outpatient)(43)

Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

Conditions: Cannabis-use Disorders
Being tested: Pregabalin, Placebo
Keywords: marijuana, addiction, treatment, pharmacotherapy, cannabinoid
Medical subject headings: Marijuana Abuse, Behavior, Addictive

What participants receive

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

PregabalinDrug
pregabalin 2x daily for duration of study
PlaceboDrug
placebo 2x daily for duration of study

Study groups in NCT01511640
Study group	Role	What they receive
Pregabalin 1	Experimental	Dose 1 Receives: Drug: Pregabalin
Placebo 1	Placebo comparator	Placebo 1 Receives: Drug: Placebo
Pregabalin 2	Experimental	Dose 2 Receives: Drug: Pregabalin
Placebo 2	Placebo comparator	Placebo 2 Receives: Drug: Placebo

What is being measured

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

Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance.
Measured: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.

Timeline

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

1 Feb 201715 Mar 2020

First posted18 Jan 2012 (estimated)
Study start1 Feb 2017
Primary completion15 Mar 2020
Study completion15 Mar 2020

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 Cannabis-use DisordersStudies 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01511640
Sponsor's protocol ID: R01DA036550
Status last verified: Aug 2021
First submitted: 9 Jan 2012
Last updated: 10 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cannabis-use Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Effects of Drugs (Outpatient)(43)
ClinicalTrials.gov ID: NCT01511640
Acronym / sponsor ID: R01DA036550
Conditions: Cannabis-use Disorders
Keywords: marijuana, addiction, treatment, pharmacotherapy, cannabinoid
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Joshua A. Lile, Ph.D.University, hospital or other
Study start: 1 Feb 2017 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 15 Mar 2020 (actual)
First posted: 18 Jan 2012 (estimated)
Results: Posted 10 Sep 2021

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: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Pregabalin 1	Experimental	Drug: PregabalinDose 1
Placebo 1	Placebo comparator	Drug: PlaceboPlacebo 1
Pregabalin 2	Experimental	Drug: PregabalinDose 2
Placebo 2	Placebo comparator	Drug: PlaceboPlacebo 2

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

regular cannabis use
good health other than cannabis use
willingness to attempt abstinence
effective form of birth control in female subjects
available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each

Key exclusion criteria (2 listed)

medical screening outcomes outside normal ranges or deemed clinically insignificant
medical history that would contraindicate pregabalin administration

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
Pregabalinpregabalin 2x daily for duration of study	Drug	Pregabalin 1, Pregabalin 2
Placeboplacebo 2x daily for duration of study	Drug	Placebo 1, Placebo 2

Primary outcome

Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
Time frame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance.

Results and safety

Results posted to the registry on 10 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
300 mg/Day Pregabalin, Then Placebo	7	5
Placebo, Then 300 mg/Day Pregabalin	8	8
450 mg/Day Pregabalin, Then Placebo	7	7
Placebo, Then 450 mg/Day Pregabalin	8	7

Primary outcome: Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions

Time frame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.. Mean (Standard Error). Unit: Cannabis puffs

Measure	300 mg/Day Pregabalin n = 12	0 mg/Day Pregabalin (Placebo 1) n = 12	450 mg/Day Pregabalin n = 13	0 mg/Day Pregabalin (Placebo 2) n = 14
0% placebo Cannabis	2.00 (0.92)	2.67 (0.92)	3.60 (1.15)	4.00 (0.88)
5.9% active Cannabis	5.75 (0.95)	5.67 (0.77)	5.40 (0.85)	4.80 (0.76)

Adverse events

Time frame: 22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
300 mg/Day Pregabalin	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
0 mg/Day Pregabalin (Placebo 1)	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
450 mg/Day PregabalinPregabalin	0 of 13 (0%)	0 of 13 (0%)	0 of 13
0 mg/Day Pregabalin (Placebo 2)	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Joshua A. Lile, Ph.D. 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 Pregabalin in people with Cannabis-use Disorders, run by Joshua A. Lile, Ph.D. 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 2021. 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 10 Sep 2021). 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 Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions (time frame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.). 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 NCT01511640.

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 10 Sep 2021.