Alcohol DependencePhase 2NCT01151813

Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving

A Phase 2 study testing Varenicline in people with Alcohol Dependence and Cocaine Dependence, run by University of Pennsylvania 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

This is a Phase II within-subjects double-blind placebo-controlled human laboratory study. The purpose of the study is to determine the efficacy of varenicline (Chantix) for reducing cue-induced cocaine and alcohol craving. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Alcohol Dependence, Cocaine Dependence
What is being tested?: Varenicline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Dec 2013
Phase: Phase 2
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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is male or female and is between 21 and 65 years of age.
The subject has used cocaine, alcohol, or cocaine and alcohol at least once per month for at least the past year, and has used cocaine, alcohol, or cocaine and alcohol within the past 30 days.
Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
Understands and signs the informed consent.

Who cannot join

Meets DSM-IV criteria for current dependence on any substance other than nicotine, cocaine, alcohol or marijuana.
Subjects who are currently taking anti-depressant medications (e.g., SSRIs such as citalopram)
Patients who are diagnosed during screening with clinical depression using the HAM-D rating scale and present with a score >10.
Subjects who are diagnosed with anxiety as diagnosed using the HAM-A anxiety scale with a score >17
Subjects who meet current- or lifetime DSM-IV criteria for a psychotic disorder (e.g., schizophrenia)
Requires treatment with any psychotropic medication (e.g., antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication).

Show all 26Show fewer

Subjects who test positive on the urine drug screen for any illicit drugs other than cocaine and marijuana during screening will be allowed a single retest. Those individuals who test positive for amphetamine during screening, given that they provide a copy of a prescription, will only be included if they can safely discontinue amphetamine use for the duration of the study. Subjects will need to provide a urine free of all illicit drugs other than cocaine and marijuana at study onset to be randomized. Subjects who test positive for any drugs other than marijuana prior to a study session will be allowed a single retest and a chance to reschedule their session. If the subject tests positive for any drug other than marijuana at the retest, their participation in the study will be terminated.
Use of any investigational medication within the past 30 days.
Concomitant use of any one of the following drugs or classes of drugs:
Anti-depressant drugs such as citalopram, fluoxetine; antipsychotic drugs such as haloperidol; benzodiazepines or other anxiolytic medications; Antihypertensive drugs such as Reserpine, Verapamil; Blood thinners Medications used to treat respiratory diseases such as theophylline; Trimethoprim; Cimetidine; Antiepileptic drugs (AEDs) such as phenytoin or valproic acid.
Patients with a known hypersensitivity to varenicline.
Patients with severe unstable or serious medical illness such as a seizure disorder, unstable cerebrovascular disease, bronchospastic disease, hyperthyroidism, or diabetes mellitus.
Patients with known AIDS or other serious illnesses that may require hospitalization during the study.
Female subjects who are pregnant, plan to become pregnant, are currently lactating, or are of child-bearing potential and are not using acceptable methods of birth control; acceptable methods of birth control would include:
Barrier method (diaphragm or condom)
Intrauterine progesterone contraceptive system
Levonorgesterel implant
Medroxyprogesterone acetate contraceptive injection, or
Oral contraceptives.
Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).
An unacceptable liver panel (liver function tests; LFTs) that may be indicative of hepatic dysfunction.
Clinical laboratory tests (e.g., CBC, blood chemistries, urinalysis) outside normal limits, as determined by PI.
History of significant heart disease or dysfunction (e.g., an arrhythmia which required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
History of chest pain associated with cocaine use that prompted a visit to a physician.
Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Conditions: Alcohol Dependence, Cocaine Dependence
Being tested: Varenicline, Placebo
Medical subject headings: Alcoholism, Cocaine-Related Disorders

What participants receive

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

VareniclineDrug
Also called Chantix
Varenicline, oral target dose of 1.0 mg BID, one week titration.
PlaceboDrug
Placebo

Study groups in NCT01151813
Study group	Role	What they receive
Varenicline	Active comparator	Varenicline, oral administration for 1 week Receives: Drug: Varenicline
Placebo	Placebo comparator	Placebo, oral administration for 1 week Receives: Drug: Placebo

What is being measured

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

Visual Analog Scale Alcohol Craving
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicates no craving 100 indicates strongest possible craving.
Measured: average value over one week
Visual Analog Scale Cocaine Craving
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated.
Measured: average value over one week
Visual Analog Scale Alcohol Craving 2
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving
Measured: average over one week
Visual Analog Scale Cocaine Craving 2
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving
Measured: average over one week

Timeline

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

Jul 2010Dec 2013

First posted28 Jun 2010 (estimated)
Study startJul 2010
Primary completionAug 2013
Study completionDec 2013

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 Alcohol DependenceStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01151813
Sponsor's protocol ID: 811289
Other IDs: K01DA025073
Status last verified: Aug 2020
First submitted: 25 Jun 2010
Last updated: 18 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving
ClinicalTrials.gov ID: NCT01151813
Acronym / sponsor ID: 811289
Conditions: Alcohol Dependence, Cocaine Dependence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jul 2010
Primary completion: Aug 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 28 Jun 2010 (estimated)
Results: Posted 18 Aug 2020

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Varenicline	Active comparator	Drug: VareniclineVarenicline, oral administration for 1 week
Placebo	Placebo comparator	Drug: PlaceboPlacebo, oral administration for 1 week

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is male or female and is between 21 and 65 years of age.
The subject has used cocaine, alcohol, or cocaine and alcohol at least once per month for at least the past year, and has used cocaine, alcohol, or cocaine and alcohol within the past 30 days.
Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
Understands and signs the informed consent.

Key exclusion criteria (26 listed)

Meets DSM-IV criteria for current dependence on any substance other than nicotine, cocaine, alcohol or marijuana.
Subjects who are currently taking anti-depressant medications (e.g., SSRIs such as citalopram)
Patients who are diagnosed during screening with clinical depression using the HAM-D rating scale and present with a score >10.
Subjects who are diagnosed with anxiety as diagnosed using the HAM-A anxiety scale with a score >17
Subjects who meet current- or lifetime DSM-IV criteria for a psychotic disorder (e.g., schizophrenia)

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
VareniclineAlso: ChantixVarenicline, oral target dose of 1.0 mg BID, one week titration.	Drug	Varenicline
PlaceboPlacebo	Drug	Placebo

Primary outcome

Visual Analog Scale Alcohol Craving
Time frame: average value over one week
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicates no craving 100 indicates strongest possible craving.
Visual Analog Scale Cocaine Craving
Time frame: average value over one week
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated.
Visual Analog Scale Alcohol Craving 2
Time frame: average over one week
Visual Analog Scale specific to alcohol craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for alcohol. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving
Visual Analog Scale Cocaine Craving 2
Time frame: average over one week
Visual Analog Scale specific to cocaine craving. The VAS has a 100 mm line anchored by 0 and 100. Participants mark the line to indicate how strong their craving is for cocaine. 0 indicated no craving, 100 represents the worst craving imaginable. The subject draws a hatch mark line along the line closer to where there current craving is rated. Closer to the 0 means less craving, closer to the 100 means more craving

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline First, Then Placebo	8	8
Placebo First, Then Varenicline	7	7

Primary outcome: Visual Analog Scale Alcohol Craving

Time frame: average value over one week. Mean (Full Range). Unit: units on a scale

Measure	Varenicline First, Then Placebo n = 8	Placebo First, Then Varenicline n = 7
Value	20 (0 to 100)	35 (0 to 100)

Varenicline First, Then Placebo vs Placebo First, Then Varenicline: p = .02, t-test, 2 sided

Population analysed: Comparing alcohol craving during Varenicline treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Primary outcome: Visual Analog Scale Cocaine Craving

Time frame: average value over one week. Mean (Full Range). Unit: units on a scale

Measure	Varenicline First, Then Placebo n = 8	Placebo First, Then Varenicline n = 7
Value	25 (0 to 100)	65 (0 to 100)

Varenicline First, Then Placebo vs Placebo First, Then Varenicline: p = 0.03, t-test, 2 sided

Population analysed: Comparing cocaine craving during Varenicline treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Primary outcome: Visual Analog Scale Alcohol Craving 2

Time frame: average over one week. Mean (Full Range). Unit: units on a scale

Measure	Varenicline First, Then Placebo n = 8	Placebo First, Then Varenicline n = 7
Value	35 (0 to 100)	55 (0 to 100)

Varenicline First, Then Placebo vs Placebo First, Then Varenicline: p = 0.03, t-test, 2 sided

Population analysed: Comparing alcohol craving during Placebo treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Primary outcome: Visual Analog Scale Cocaine Craving 2

Time frame: average over one week. Mean (Full Range). Unit: units on a scale

Measure	Varenicline First, Then Placebo n = 8	Placebo First, Then Varenicline n = 7
Value	65 (0 to 100)	80 (0 to 100)

Varenicline First, Then Placebo vs Placebo First, Then Varenicline: p = 0.04, t-test, 2 sided

Population analysed: Comparing cocaine craving during Placebo treatment in participants initially treated with Varenicline (Group 1) to those initially treated with Placebo (Group 2).

Adverse events

Time frame: through study completion, two weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Placebo	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Varenicline in people with Alcohol Dependence and Cocaine Dependence, run by University of Pennsylvania 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 4 inclusion and 26 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 18 Aug 2020. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 Aug 2020). 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?

Visual Analog Scale Alcohol Craving (time frame: average value over one week). The study lists 4 primary outcomes in all. 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 NCT01151813.

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 18 Aug 2020.