Clinical trial NCT03253926
Conditions: Cannabis Use
Sponsor: New York State Psychiatric Institute
Start date: 2017-09-05; Completion date: 2021-12-31
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Detailed description:
In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have developed a laboratory model to investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non treatment-seeking cannabis smokers. In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lorcaserin intervention 2: Placebo intervention 3: Marijuana
Intervention descriptions: intervention 1: Lorcaserin 10mg BID intervention 2: Placebo capsule BID intervention 3: Smoked marijuana cigarette

Protocol documents:
ICF_002.pdf: 
Dr. Haney, 7/11/17 
IRB#7475 
 
1 
 SUMMARY SHEET 
The following outline is meant to serve as a guide to help you learn about this research study 
and decide whether or not you want to take part. It does not replace the consent form that you 
will be asked to read and sign. The consent includes much more information you’ll need to 
make a decision. Read the consent form carefully, ask questions and take your time to speak to 
others if you want to before you make your choice. Remember, even if you agree to take part in 
research you can change your mind at any time. 
PURPOSE: To study how medications influence the effects of marijuana and your choice to 
smoke marijuana. 
ALTERNATIVES:  Since this is not a treatment study, the alternative is not to participate.  
PROCEDURES:  
• This study has two 11-day inpatient phases. Before each inpatient phase, you will be asked to 
briefly come into the laboratory for two consecutive days to start taking medication. On these 
two days, you will receive a morning capsule in the laboratory and then take your evening 
capsule at home. We will check your urine to confirm that you have taken your evening dose. 
After the 2nd day, you will move-in to the lab, and you will then spend 11 full days as an 
inpatient prior to move out. 
• While you are inpatient, you will not be able to have your cell phone, make telephone calls, 
access the internet or news or receive visitors. Capsules will be administered every morning and 
evening.  
• During the outpatient phase, you will not take capsules and you will not have to come to the 
laboratory. 
• Marijuana cigarettes will be available on some inpatient days, but there will also be days when 
no marijuana is available.  
• On the days marijuana is available, it will either be given to you by the investigators to smoke at 
set timepoints at no cost to you or you will have the option of purchasing individual puffs of 
marijuana (using your study earnings).  
• You will never be required to spend your earnings on marijuana; this will always be your 
choice. 
RISKS 
• Smoking marijuana produces effects such as increased appetite, tiredness, shakiness, and heart 
pounding.  
• Smoking less marijuana than you are used to can also produce side effects, such as irritability, 
trouble sleeping, restlessness, anxiety and loss of appetite.  
• Most common side effects from the medications are headache, diarrhea, dizziness, constipation, 
cold-like symptoms, trouble sleeping, dry mouth and changes in appetite. 
• You will be informed of any new findings that may affect your willingness to continue in this 
study. 
BENEFITS:  The study is not designed to benefit you directly.  


Dr. Haney, 7/11/17 
IRB#7475 
 
2 
NEW YORK STATE PSYCHIATRIC INSTITUTE 
COLUMBIA UNIVERSITY DEPARTMENT OF PSYCHIATRY 
CLINICAL INVESTIGATION CONSENT FORM 
Purpose of Study 
The purpose of this research is to study how medications influence the effects of smoked marijuana. 
You will receive any of three medications, all of which are approved by the Food and Drug 
Administration (FDA). You are being asked to participate because you regularly smoke marijuana, 
and if you are a woman, you are not pregnant. This study is funded by a grant from the National 
Institute on Health. 
Participation is Voluntary  
Participation in this project is voluntary, and you may refuse to participate or discontinue 
participation at any time without loss of benefits to which you are otherwise entitled. You will be 
informed of any new findings or risks that arise that may affect your willingness to continue in this 
study. A decision not to participate in this study or to withdraw at any time will not affect your 
present or future medical care at either the Columbia-Presbyterian Medical Center or the NYS 
Psychiatric Institute. The investigator may also decide that your participation should be discontinued, 
if he/she thinks that this is better for you.  
Medications 
As part of this study, we will ask you to smoke marijuana.  
You may be given the following medications: (1) bupropion (ZYBAN®) used to help people quit 
smoking cigarettes, (2) lorcaserin (BELVIQ®) a weight loss drug, or (3) ondansetron (ZOFRAN®) 
used to prevent nausea and vomiting. You may also receive placebo capsules (sometimes called 
‘sugar pills’). Placebos look like the other capsules but have no active medicine. Neither you nor the 
research staff will know which capsules you got, but the investigators can find out. You and the 
other participants may not receive the same dose of medication at the same time.  
Alternatives to Participation 
This is not a treatment study; data are being collected for research only, to learn more about the 
effects of marijuana and medications, not to study you personally. The alternative is to not 
participate in the study. If you are interested in treatment, we will give you a referral to a treatment 
program.  
Study Procedures 
Before the Study Starts  
We have told you what living in the Residential Laboratory is like to help you decide if you want to 
do the study. Women have been given a pregnancy test at screening and will be tested again before 
taking medications and prior to each inpatient phase. If pregnant, you will not be eligible to 
participate. If you think you might be pregnant, please tell the investigator. It is very important that 
women practice an effective method of contraception for the entire study, and you must agree to do 
so as part of your participation.  
You will also have the opportunity to participate in an optional study to measure the influence of 
genetic or hereditary differences in how people respond to marijuana. In order to participate in this 
procedure, you will receive a separate consent form, asking you to provide a blood or buccal (cheek 
swab) sample for DNA testing. Your decision to participate in this procedure has no effect on your 
participation in the main study. You will also have the right to withdraw consent from this additional 


Dr. Haney, 7/11/17 
IRB#7475 
 
3 
procedure at any time by asking that your sample be destroyed, without affecting your participation 
in the main study.    
Study Schedule 
The study has two inpatient phases (where you sleep in the laboratory), each lasting eleven full days, 
plus a move-in and a move-out day. Before each move-in day, you will be asked to complete two 
brief outpatient sessions in our laboratory, where we will ask you to take your morning capsule and 
take home your evening capsule. We will test your urine to confirm you took your evening capsule.  
During the inpatient phases and the outpatient dosing sessions, you will receive capsules twice/day. 
Between the two inpatient phases will be an outpatient phase lasting at least seven days (where you 
will be free to live as you currently do without taking capsules).  
Each inpatient day is like a 9-5 workday. We will wake you up around 8AM. We will collect your 
urine each morning, weigh you and measure your heart rate and blood pressure. You will be given 
mood questionnaires and a series of computer tasks to complete at set periods throughout the day, 
and we ask that you complete the tasks as quickly and as accurately as you can. We will ask you to 
wear a small device on your wrist that looks like a watch that will record your sleep and activity 
level. In the evening, your time will be less scheduled. You can watch movies, play video games or 
relax in your room. Access to the recreation area will end at 10PM, and lights will go out at 
midnight. Study staff will watch you on cameras. No recordings will be made, but we will keep a 
record of how you spend your time. You will have privacy while sleeping and in the bathroom. You 
will always have bathroom access.  
Marijuana cigarettes will be available on certain days and not others. On days of marijuana 
availability, you will either be given individual puffs of marijuana at no cost to you or you will have 
the option of using your study earnings to purchase individual marijuana puffs if you are interested in 
smoking (maximum of 18 puffs a day). You will never be required to spend your earnings on 
marijuana; this will always be your choice.  
In order to complete the study, you will need to remain in the laboratory and follow the instructions 
we have given you. You can only eat and drink the items we have available. You cannot take any 
drugs other than those given as part of the study, and you will not be able to make telephone calls, 
access the internet, or receive visitors. We will examine your clothing and other belongings prior to 
each move-in and your room may be searched for drugs. 
After the study 
When the study is over, we will discuss study details with you that we were unable to discuss while 
you were in the study. We will also repeat your electrocardiogram. 
Risks  
You may experience side effects from the marijuana, which could include: increased appetite, 
sleepiness, anxiety, concentration difficulties, faintness, restlessness, confusion, lightheadedness, 
loss of coordination, clumsiness, shakiness, dizziness, stomach upset, headache, paleness, nausea, 
flushing, sweating, dry mouth, slurred speech, fatigue, itching, heart pounding, and changes in the 
pattern of heart beats.  
You may also experience withdrawal if the amount of marijuana smoked in the study is less than 
what you normally smoke. Symptoms of marijuana withdrawal can include sleep difficulty, 
irritability, upset stomach, restlessness, anxiety and loss of appetite.  
You may experience side effects from the capsules, which could include headache, dizziness, fatigue, 
nausea, dry mouth, constipation, cough, and back pain. Some rare but serious side effects include 
agitation, confusion, hallucinations, irregular heartbeat, heart valve disease, changes in your red or 


Dr. Haney, 7/11/17 
IRB#7475 
 
4 
white blood cells, depression, thoughts of suicide, and for men, an erection lasting longer than 4 
hours. You should use caution if you drink alcohol, drive a motor vehicle or operate heavy machinery 
until you know how the capsules affect you. Since some of the capsules you may receive can affect 
serotonin levels in your body, you should not take any medications including dietary supplements, as 
this can lead to a potentially life-threatening drug reaction. We will watch you carefully throughout 
your participation to minimize the chance of any serious reactions.  
Blood drawing may result in some discomfort at the site of needle entry, which could result in a small 
bruise. Finally, living in the residential laboratory may be boring.  
The risk of using marijuana while taking study medications is not known. The medications listed 
above are safe when taken as recommended, but their effects in combination with marijuana have 
not been tested. They may increase, decrease or have no effect on how marijuana makes you feel. 
Benefits 
This study is not designed to directly benefit you. The benefits of participating in the research relate 
primarily to the general scientific value of gaining a better understanding of drug effects on behavior.  
Compensation.  
You will receive $25 for every screening, training, and outpatient dosing visit. You will be paid $40 
for each move-in day and $25 for each move-out day, $45/inpatient test day and a bonus $45/inpatient 
test day if you complete the entire study. Study payments are made in cash upon completion of the 
second inpatient phase. In order to prevent a single large payment, you will receive half of your study 
pay in cash upon discharge. We will ask you to return to the laboratory for the second half of the 
payment the following week. Total payment (including screening pay) for your study participation will 
range from $1,850-$2,235, depending on how many screening and training visits you are asked to 
attend, how much money you choose to spend on marijuana, and whether you choose to participate in 
the genetic study. 
Because payment is over $600, we are required by law to report your earnings to the IRS. Therefore, 
your Social Security Number and amount earned will be reported, and you will receive the 
appropriate IRS form at the end of the year in which you were paid. Please note that payment for this 
study may affect your eligibility for Medicaid and other city and state support services. No 
information about which study you participated in will be provided to the IRS. 
Confidentiality. We will apply for a Federal Certificate of Confidentiality for this study, which 
protects the investigators from having to release the names or other identifying characteristics of 
research subjects. Investigators so authorized may not be compelled in any Federal, State or Local, 
civil, criminal, administrative, legislative or other proceedings to provide identifying information 
about research participants even if subpoenaed without your written consent. Although this certificate 
protects against involuntary disclosure, you may voluntarily disclose research data or information to 
physicians or other third parties. You may also authorize in writing the investigator to release the 
information to insurers, employers, or other third parties. Additionally, this certificate does not 
prevent the researchers from the voluntary reporting matters such as child abuse, reportable 
communicable diseases, or subject's threatened violence to self or others. Such information will be 
reported to the appropriate authorities.  
When results of this study are presented or published, your name will not be used. Your name and other 
personal identifying information will be stored in an electronically secure database at the New York State 
Psychiatric Institute. Research records will only be available to research staff and the Food and Drug 
Administration (FDA); signed consent forms will be kept in a locked file; electronic data will be 
maintained on password-protected computers. Once you are enrolled into the study, only your initials and 


Dr. Haney, 7/11/17 
IRB#7475 
 
5 
your assigned number will be used to identify you on all documents, including electronic documents that 
may be used for storage. 
Research Standards and Participants’ Rights 
Compensation for Research Related Injuries:  
Federal regulations require that we inform you about our institution's policy with regard to 
compensation and payment for treatment of research-related injuries. If you believe that you have 
sustained an injury as a result of participating in a research study, you may contact Dr. Haney at 
(646) 774-6153 so that you can review the matter and identify the medical resources that may be 
available to you. In case of injury, the New York State Psychiatric Institute, Columbia University and 
New York Presbyterian Hospital will furnish that emergency medical care determined to be necessary 
by the medical staff of this hospital. In addition, we will provide assistance in arranging follow up 
care in such instances. You will be responsible for the cost of such care, either personally or through 
your medical insurance or other form of medical coverage. No monetary compensation for wages lost 
as a result of injury will be paid to you by Research Foundation for Mental Hygiene, the New York 
State Psychiatric Institute, Columbia University, or by New York Presbyterian Hospital. By signing 
this consent form, you are not waiving any of your legal rights to seek compensation through the 
courts. 
Questions:   
The investigators will answer, to the best of their ability, any questions you may have now or in the 
future regarding study procedures or your response to them. You can call the principal investigator, 
Dr. Haney if you have any questions at (646) 774-6153. If you have any questions about your rights 
as a research participant, want to provide feedback, or have a complaint, you may call the NYSPI 
Institutional Review Board (IRB). An IRB is a committee that protects the rights of participants in 
research studies. You may call the IRB main office at (646) 774-7155 during regular office hours.  
You will be given a copy of this consent form to keep. 
 
Statement of consent 
I have discussed this study with  
 
 
 
 
 to my satisfaction. To the best of 
my knowledge, I am not pregnant. I understand that my participation is voluntary, and that I can 
withdraw from the study at any time without prejudice.   
 
I have read the above, and I voluntarily agree to enter this research study. 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Subject 
 
 
 
 
 
 
Date 
 
 
Statement of the Investigator obtaining Consent 
I have discussed the proposed research with this participant and, in my opinion, this participant understands 
the benefits, risks and alternatives (including non participation) and is capable of freely consenting to 
participate in this research. 


Dr. Haney, 7/11/17 
IRB#7475 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator obtaining consent  
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
Statement of the Physician Investigator 
I have discussed the proposed research with this participant and, in my opinion, this participant understands 
the benefits, risks and alternatives (including non participation) and is capable of freely consenting to 
participate in this research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Study Physician obtaining consent 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
Printed Name of Study Physician 

SAP_004.pdf: 
NYSPI Protocol Number: 7475 
 
Protocol Title: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration 
 
Principal Investigator: Margaret Haney, PhD 
 
NCT03253926 
 
Date: 06/29/2022 
 
 
 


Data Analysis Plan 
 
Repeated measures analyses of variance including two within-subject factors (medication dose, 
and inpatient day) with planned comparisons were used to determine the effects of lorcaserin, 
relative to placebo, on (primary outcome) cannabis self-administration under abstinent and non-
abstinent conditions and (secondary outcome) subjective effects following controlled cannabis 
administration. Other secondary outcomes included the following: number of cannabis puffs that 
were self-administered, daily peak subjective-effects ratings, drug craving, objective and 
subjective sleep measures, food intake (total energy intake, percent macronutrient [fat, protein, 
and carbohydrate]), body weight, blood pressure and heart rate. Significance was determined at 
α = 0.02. Huynh–Feldt corrections were used. Note that repeated-measures, within-subject 
designs result in substantial correlations between levels and are a powerful statistical approach. 
Based on a previous study from our group, a sample size of 15 study completers provides >90% 
power to detect changes in cannabis self-administration and subjective effects as a function of 
lorcaserin versus placebo. Effects of lorcaserin on the frequency of side effects were assessed 
using sign test, a nonparametric test used to identify consistent differences between pairs of 
observations (lorcaserin vs. placebo). 

Prot_000.pdf: 
Uploaded Protocol Summary Form 
 
Cover Page 
Background, Significance, and Rationale 
 
 
 
 
 
Protocol Number: 7475 
Version Date: 6/12/18 
Protocol Title: Effect of Lorcaserin on Cannabis Withdrawal and Self-administration 
Principal Investigator: Margaret Haney, PhD 
Email: mh235@cumc.columbia.edu 
Telephone: 646-774-6153 
Office: 
Cell 
NCT03253926 
 
 
 
 
This section is intended to provide a basic overview of the study including a description of its purpose, methods, and 
subject population. The summary should provide a concise overview of the study for non-scientific and scientific 
members of the IRB. Please avoid medical or technical terminology. In general, the abstract of a grant does not provide 
a suitable lay summary. 
Please also paste of a copy of the Lay Summary into the PRISM PSF Form. 
 
In order to improve treatment outcome for cannabis use disorder (CUD), we have developed a laboratory model to 
investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing 
effects of cannabis in non treatment-seeking, cannabis smokers. In this study, we are interested in testing how 
lorcaserin (10 mg, BID) influences the effects of cannabis and the choice to smoke cannabis in this human laboratory 
model of cannabis administration. Lorcaserin is a well tolerated, selective 5HT2c agonist that is FDA-approved for the 
treatment of obesity. 5HT2c receptors are abundant in areas rich in dopamine neurons (Abramowski et al., 1995) and 
are involved in modulating impulsive behaviors and reactivity to drug-related cues (Anastasio et al., 2013; Cunningham 
and Anastasio, 2013). Recent preclinical data show that lorcarserin reduces THC self-administration and relapse in non- 
human primates (Justinova et al., unpublished). We hypothesize that lorcaserin will decrease cannabis withdrawal 
symptoms and cannabis relapse in this human laboratory model. 
 
In this section, provide a brief summary of the status quo of the relevant work field, and how the proposed study will 
advance knowledge. Specifically, identify the gaps in knowledge that your project is intended to fill. If no gaps exist that 
are obviously and directly related to your project, explain how your proposed research will contribute to the overall 
understanding of your field. Describe potential impacts of your project within your field of study and in a broader context. 
Provide a critical evaluation of existing knowledge. The literature review does not have to be exhaustive. 
 
Cannabis use is increasing (SAMHSA, 2012) and numbers are likely to rise further with legalization; residents of states 
with medical cannabis laws have higher odds of cannabis use and higher rates of DSM-V abuse/dependence compared 
to states without these laws (Cerdá et al., 2012). Almost 20% of patients entering treatment for substance use disorders 
have a diagnosis of cannabis use disorder (CUD; SAMHSA, 2013), yet their outcome is poor. Only 15%–37% of patients 
achieve continued abstinence from cannabis following clinical treatment (MTPRG, 2004; Budney et al., 2006; Kadden et 
al., 2007; Levin et al., 2011). There is a clear need for FDA-approved pharmacological options to improve cannabis 
Lay Summary 


Uploaded Protocol Summary Form 
 
 
 
treatment outcomes. Human laboratory studies provide a powerful means of investigating potential medications for 
drug treatment, and are an important precursor to guide expensive clinical trials (Koob et al., 2009). 
 
The overall aim of this study is to test the effects of lorcaserin on a range of clinically-relevant behaviors: cannabis self- 
administration under non-abstinent conditions, relapse to cannabis use, mood, sleep, food intake, and cognitive task 
performance. This drug is of interest because 5HT2c agonists influence behaviors motivated by a wide range of 
reinforcers. In preclinical studies, 5HT2c agonists, including lorcaserin, reduce the stimulant, discriminative stimulus and 
reinforcing properties of nicotine, ethanol and cocaine, as well as reinstatement of nicotine and cocaine seeking 
(Grottick et al., 2000; Fletcher et al., 2012; Cunningham et al., 2011; Higgins et al., 2013; Collins et al. 2016). These 
effects persisted with repeated medication administration (e.g., Yamauchi et al., 2004), essential for a treatment 
medication. Similar to obesity, the indication for which lorcaserin is approved, substance use disorders reflect learned 
behaviors that persist despite negative consequences (e.g., Bickel et al, 1999; Fields et al., 2009). Lorcaserin is currently 
in clinical testing as an aid for smoking cessation (ClinicalTrials.gov: NCT02044874) and a treatment for cocaine-use 
disorder (studies NCT02680288, NCT02537873). 
 
In non-human primates, pretreatment with 5-HT2c agonist lorcaserin dose-dependently reduced THC self-administration 
behavior at a dose (4 μg/kg/inj.) that maintains high rates of drug taking behavior. In a model of relapse, lorcaserin also 
dose-dependently reduced cue-induced reinstatement of previously extinguished THC-seeking behavior. However, 
lorcaserin did not affect THC priming-induced reinstatement. At the doses that affected THC self-administration and 
reinstatement, lorcaserin did not reduce food-maintained self-administration under the same schedule of reinforcement 
(Justinova, unpublished data). These findings suggest that lorcaserin could be a novel treatment for CUD. 
 
 Specific Aims and Hypotheses 
 
Concisely state the objectives of the study and the hypothesis or primary research question(s) being examined. There 
should be one hypothesis for every major study procedure or intervention. For pilot studies, it is important not to 
overstate the study's objectives. If there are no study hypotheses, describe broad study goals/aims. 
 
The overall aim is to test the effects of lorcaserin on a range of clinically relevant behaviors: cannabis self- 
administration, relapse to cannabis use, mood, sleep, food intake, and cognitive task performance. We hypothesize that 
lorcaserin will attenuate cannabis’ positive subjective effects and facilitate abstinence initiation, i.e., reduce cannabis 
self-administration under non-abstinent conditions, as well as reducing relapse to cannabis use. 
 
Inclusion/Exclusion Criteria 
 
This section details your study sample(s) and addresses the requirement for risk minimization. 
You may choose to divide your sample by population (healthy controls vs. subjects) or by procedure (subjects who will 
have an MRI) and then define different sets of criteria for each. 
For each sample, create or insert a table to describe detailed criteria for study inclusion and exclusion and the method 
you will use to ascertain each criterion. The method of ascertainment may describe tests, scales and instruments. When 
relevant, indicate the level of training of the person who will make the assessment (e.g. clinical interview by a 
psychiatrist). 
Inclusion/Exclusion Criteria needs to be numbered and listed in outline form (see Table template below). 
 
Name the subject group/sub sample 
Healthy Cannabis Smokers 


Uploaded Protocol Summary Form 
 
 
CRITERION 
METHOD OF ASCERTAINMENT 
Inclusion: 
1. Current cannabis use: average of 2 
cannabis cigarettes per day at least 6x/ week 
for the past 4 weeks 
Self-report during clinical interviews (telephone, 
psychologist, physician), urine toxicology 
2. Able to perform study procedures 
Practice sessions, physician’s physical and 
mental status examination 
3. 21-50 years of age 
Legal identification 
4. Women practicing an effective form of 
birth control (condoms, diaphragm, birth 
control pill, IUD) 
Self-report during clinical interview, physician’s 
evaluation 
5. English Speaking 
Clinical interview, ability to complete screening 
paperwork 
6. Able to give informed consent 
Clinical interview, physician’s mental status 
examination 
Exclusion: 
1. Current diagnosis of an eating disorder 
(anorexia, bulimia, etc.) or have lost more 
than 10% of their body weight within the last 
3 months and a known sensitivity, allergy or 
contraindication to lorcaserin or similar 
medications 
Medical history, physical examination 
2. Current, repeated (>2x/week) illicit drug 
use other than cannabis 
Clinical interview, physicians evaluation, urine 
toxicology 
3. Presence of any clinically significant 
cardiovascular, respiratory, renal, 
gastrointestinal, hematologic, neurologic, 
pulmonary, immunologic, hepatic, endocrine, 
or other abnormality 
Medical history, physical examination, 12-lead 
ECG, laboratory tests (Chem panel, CBC, 
urinalysis) 
4. History of heart disease and cardiac risk 
factors (congestive heart failure, edema, 
unstable angina, or cardiac arrhythmias), 
blood pressure > 140/90, severe chronic 
obstructive pulmonary disease, uncontrolled 
hypertension or diabetes, or other medical 
condition that would make participation 
hazardous 
Self-report, clinical interview, abnormal ECG, 
Medical history, physical examination 
5. Interest in treatment for cannabis use 
Self-report, clinical interview 
6. Current parole or probation 
Self-report, clinical interview 
7. Current pregnancy or lactation 
Clinical interview, physical examination, 
pregnancy testing (serum HCG) 


Uploaded Protocol Summary Form 
 
 
8. Recent history of significant violent 
behavior (past year) 
Self-report, clinical interview 
9. Current Axis I psychopathology requiring 
medical intervention (e.g., bipolar disorder, 
major depressive disorder, suicide risk, 
schizophrenia) 
Clinical interview; diagnoses determined by a 
clinical interview via the SCID, as confirmed by 
the psychiatric evaluation 
10. Current use of any prescription or over- 
the-counter medication 
Clinical interview, medical history, physical 
examination 
 
 
Study Procedures 
 
Provide a clear, concise narrative of study procedures with special attention to the subjects' involvement. Detail the 
overall study timeline and location of study procedures, list all interventions, assessments and interviews, estimate the 
duration of each procedure, provide dosing schedules, identify study personnel involved in each procedure, and provide 
credentials for relevant personnel. For complicated study designs, we strongly encourage attaching tables, flow-charts, 
and study algorithms. 
 
General design: This within-subject study will have two 11-day inpatient phases, with one phase testing lorcaserin and 
the other phase testing placebo maintenance in counter-balanced order. In between the two inpatient phases, there will 
be a minimum 7-day outpatient period with no medication administration to provide time for medication clearance and 
the resumption of daily cannabis use. Inpatient phases will be preceded by two brief outpatient days of lorcaserin 
administration and a move-in day so that by Day 1 of each inpatient phase, participants will have achieved steady state 
conditions (3 days of 10 mg BID lorcaserin administration). On outpatient dosing days, participants will take their AM 
capsule under observation and will take their PM capsule (2030) at home. On the third day (move-in day), they will take 
their AM capsule under observation and then receive their PM capsule after moving into the laboratory. While inpatient, 
AM and PM capsules will always be administered under observation. 
 
Outpatient Dosing Visits: Participants will undergo two outpatient dosing visits immediately prior to each inpatient 
phase. On outpatient dosing days, participants will be administered capsules (lorcaserin or placebo, depending on 
phase) at 0900 under observation and will take their PM capsule (2030) at home. During outpatient dosing visits and 
move-in day, research staff will measure vital signs, urine toxicology, conduct at Timeline Followback and document any 
reported side effects from the medications. Staff will also ask about any medication or dietary supplement use. 
Participants will move into the residential laboratory (NYSPI, Division on Substance Use) the morning of the third 
outpatient dosing visit. They will be given the option to contribute a DNA sample on move-in day. We will over-enroll 
during the first outpatient phase, starting up to 7 individuals on medication, in order to ensure that we will have the 
maximum number of participants that can stay in the residential laboratory (n=4) on move-in day. 
 
Inpatient Phase: Immediately before the onset of each new medication phase, female participants will have a urine 
pregnancy test. The overall design and daily inpatient schedule is outlined in the attached tables (Table 1 and 2). We will 
assess vital signs each morning. On move-in day, we will instruct participants on how to smoke marijuana using the 
paced puffing procedure and will inform them that this is the strength available for self-administration. On the first full 
inpatient day (day 1), participants will smoke experimenter-administered cannabis 6 times (3 puffs/occasion). The 
purpose of this day is to standardize cannabis exposure prior to abstinence initiation. During the next 3 days (days 2-4; 
Table 1), participants will have the opportunity to purchase individual puffs of cannabis at $2/puff, at 6 time points. This 
measures the reinforcing effects of cannabis under nonabstinent conditions, and will reveal whether a medication 
facilitates abstinence initiation. On day 5, cannabis will be experimenter administered at 6 time points in order to again 
standardize cannabis exposure and assess medication effects on cannabis subjective ratings. On days 6-8, no cannabis 


Uploaded Protocol Summary Form 
 
 
 
 
will be available. This period will assess medication effects on cannabis withdrawal. For the remaining inpatient days 
(days 9-11; Table 1), participants will be presented with 6 opportunities throughout the day to purchase individuals puffs 
of cannabis ($7 first puff, $1 subsequent puffs). These days provide a laboratory measure of cannabis relapse. Money 
spent on cannabis during the inpatient phase is deducted from the total study pay at the end of the study. Participants 
will move out on Day 12 after passing the field sobriety test. Note, we will counter-balance the cannabis self- 
administration and relapse conditions across inpatient phases so participants are not able to predict the study schedule 
in the subsequent inpatient phase; sometimes the withdrawal and relapse condition will occur first and the abstinence 
initiation condition will occur second. Throughout each day, participants will wear an Actiwatch Activity Monitoring 
System (Actiwatch: Respironics Company, Bend OR), which tracks gross motor activity, and provides objective data on 
the number of hours slept and the number of awakenings (Perez et al., 2008). The Actiwatch is the size of a wristwatch. 
It will be removed briefly each evening in order to download that day’s data. Participants will also give a urine sample 
each morning upon awakening. We will conduct a urine toxicology twice/week; we will also measure extracellular 
vesicles in urine on certain inpatient days to look for biomarkers of recent marijuana use (potential preliminary data for 
future grant funding). 
 
 
Table 2: Inpatient Schedule 
0815 Wake up 
1315 
Task and Subjective-effects Batteries 
Subjective-Effects Battery 
1415 
Choice of 0, 1, 2, or 3 puffs 
Sleep questionnaire 
1430 
Cannabis administration 
Tobacco Cigarettes 
1445 
Task and Subjective-effects Batteries 
Weigh In, BP/HR Receive Food Boxes 
1545 
0830 Medication administration 
1600 
Choice of 0, 1, 2, or 3 puffs 
Cannabis administration 
0900 Task and Subjective-effects Batteries 
1615 
Task and Subjective-effects Batteries 
0945 Choice of 0, 1, 2, or 3 puffs 
1700 
Recreation period starts 
1000 Cannabis administration* 
2030 
Medication administration 
1030 Task and Subjective-effects Batteries 
2145 
Choice of 0, 1, 2, or 3 puffs 
1115 Choice of 0, 1, 2, or 3 puffs 
2200 
1130 Cannabis administration 
Recreation period ends 
Cannabis administration 
Subjective-Effects Battery 
 
 
*On experimenter-administered days, participants will not be required to purchase puffs but will be given cannabis at 
no cost at the 6 times indicated. On self-administered days, cannabis will only be administered if participants choose to 
purchase it. All medication administration is double-blind. 
 
 
Debriefing: Participants spend the morning after completion of the final inpatient phase being debriefed regarding the 
study design. Participants are encouraged to ask questions and provide recommendations for improving the experience 
(e.g., food, movies, computer games). Following debriefing, the investigator will discuss options for cannabis treatment, 
1245 Choice of 0, 1, 2, or 3 puffs 
2400 
Lights out 
1300 Cannabis administration 
1215 Task and Subjective-effects Batteries 


Uploaded Protocol Summary Form 
 
 
 
and will give participants a pamphlet for our clinic (STARS), where cannabis-specific treatment studies are underway. It 
will be emphasized that treatment is always an option, they can always contact us for referral information, or call STARS 
directly, if they are ready to stop smoking cannabis. We are careful to only enroll non-treatment seekers into our 
studies, so it is unusual for participants to express interest in treatment. However, the investigator will emphasize that 
treatment for cannabis use may be of interest in the future. We will also do a 12-lead ECG on the final study day. 
Participants will not leave the laboratory until a study physician approves the ECG. 
 
Criteria for Early Discontinuation 
 
Define criteria that will be used to exit or drop subjects from the study. Indicate the time points when such criteria will be 
applied, and describe the rating instruments, parameters, and thresholds that will lead to a decision to terminate a 
subject's participation. In addition, explain procedures for managing subjects who are dropped from the protocol. 
For treatment studies: To minimize risks to subjects, operationalized drop-out criteria should be defined so that subjects 
who worsen, or in some cases, fail to improve, are removed from the study and offered standard care. The threshold for 
drop-out should consider the level of risk associated with non-improvement for the specific disorder, the availability of 
alternatives, and the typical required duration of treatment. For example, emergence of suicidal intent, or psychosis, 
should prompt immediate clinical evaluation and withdrawal from the study. 
 
Participants will be removed from the study and assessed by a member of the clinical staff if, at any stage during 
participation, they: 1) experience a panic attack, as diagnosed by DSM-V criteria; 2) experience significant psychological 
deterioration as indicated by self-reported anxiety or depressed mood producing clinically significant distress beyond 
the discomfort typically experienced during cannabis withdrawal; 3) report suicidal ideation; or 4) show functional 
deterioration as indicated by inability to comply with study procedures or erratic or aggressive behavior. Experienced 
research staff will monitor participants for any potential medical or psychiatric issues over the course of the study in 
concert with the medical director, Dr. Frances Levin. If a patient is removed from the protocol, clinical staff will 
undertake a risk assessment and determine the appropriate course of action, including but not limited to admittance to 
the emergency department of Columbia University Medical Center, and referral for outpatient treatment. Participants 
may also be discontinued if they fail to follow the study procedures. 
 
Blood and other Biological Samples 
 
Describe how the sample will be used and indicate, when relevant, the amount of the sample. The IRB wants to know 
that the sample is sufficient for the purposes of the study, but that sampling is limited to what is minimally necessary. 
If you’ve indicated that you intend to store a sample for future use, indicate where the sample will be stored, how long 
the sample will be stored, and to what purposes the sample will eventually be put. Check the IRB website at 
http://irb.nyspi.org/irbdnn/Policies/GeneticResearch/tabid/96/Default.aspx for specific guidance and additional 
information about future use of DNA samples. 
 
We will do a complete blood chemistry and a plasma pregnancy test (15 ml blood) at screening. If participants opt to 
participate in the genetics study (IRB #6929R), and if we collect blood rather than buccal samples, an additional 15 ml 
may be drawn on an inpatient study day, totaling up to 30 mls. 
 
The collection of DNA/RNA will enable direct study of possible genetic contributions to both the patterns of behavioral 
response and biological measures associated with both illness and health. These samples will be used to investigate 
genetic contributions to drug use, abuse, and dependence. Although the focus of the research is on the study of 
addiction, we ask participants to indicate in their consent form whether they would also allow their DNA to be used for 
research on other (unforeseen) disorders. The measurement of DNA is optional, and it will be made clear to individuals 
that they are not required to volunteer for this component in order to participate in the main studies. Blood, cheek swab 


Uploaded Protocol Summary Form 
 
 
 
or saliva samples will be de-identified by Dr. Haney. Blood plasma (2 ml) and saliva samples will be will be stored at -80 
°C until they are shipped out for analysis. Dr. Haney will code samples with an ID number and have sole access to the 
codes. The samples will be sent to Dr. McGeary at Brown University or to Dr. Regina Santella of the Biomarkers Shared 
Resource center of Herbert Irving Comprehensive Cancer Center of CUMC with the accompanying ID number, age and 
gender. Drs. John McGeary and Santella has agreed to collaborate with us on these studies. They will not have access to 
any identifying information including the name, birthday, social security number, telephone number, or address of the 
participant. Once the samples are sent to the Biomarkers Shared Resource center or to Brown University, they will be 
stored in a repository to which only Drs. McGeary and Santella and his staff will have access. Cell lines will not be grown 
from the samples. Once the RNA and DNA has been extracted from the samples and analyzed for polymorphisms and 
biomarkers of interest, the data will be sent to Dr. Haney with the accompanying serial number. 
 
Assessment Instruments 
 
List all assessment instruments, indicate who will administer them, and provide an estimate the duration of each. The 
IRB wants to know that assessments instruments are appropriate measures for the purposes of the study and are no 
more burdensome than is necessary. The IRB will consider the burden of assessment instruments (in terms of time, 
sensitivity of material, etc.) in the risk/benefit analysis. Please attach copies or otherwise provide all non-standard 
instruments. 
 
Screening Instruments: 
Telephone Interview: 10 min 
Drug Use History Questionnaire: 10 min 
General Health Questionnaire: 5 min 
Medical History Questionnaire: 10 min 
Beck Depression Inventory: 5 min 
Barratt Impulsiveness Scale: 10 min 
Trauma Assessment for Adults: 5 min 
Michigan Alcoholism Screening Test (MAST): 5 min 
Physical and Psychiatric Examination: 30 min 
Laboratory Tests: 30 min 
PhD Interview (MINI SCID and drug use history interview): 30 min 
 
Objective Sleep Measures: Participants will wear an Actiwatch Activity Monitoring System that tracks gross motor 
activity (Actiwatch®: Respironics Company, Bend, OR; Kushida et al., 2001) and records objective sleep outcomes (hours 
slept, number of awakenings). We have used this system effectively to demonstrate perturbations in sleep as a function 
of cannabis withdrawal (e.g., Haney et al., 2010, 2013b). 
 
Subjective Effects: A 3-minute series of visual analog scales (VAS) in which participants indicate how they are feeling at 
that moment will be done 8 times/day. Mood states including symptoms of cannabis withdrawal (e.g., I feel irritable), 
positive subjective effects (e.g., I like the cannabis), medication effects (e.g., I feel sedated) and drug craving (e.g., I want 
to smoke cannabis) are assessed. In addition, subjective ratings of the previous night’s sleep are measured each 
morning. 
 
Tobacco Cigarette Smoking: Cigarette-smoking participants will be provided with cigarettes and a lighter upon request. 
They will report each cigarette prior to smoking it by scanning it with a bar code scanner. At the end of each day, the 
number of cigarettes smoked will be verified by removing and counting the remaining cigarettes and butts. Cigarette use 
is an important predictor of cannabis relapse (Haney et al., 2013a). 
 
Performance Battery: A 25-minute battery, comprising a Digit-Symbol Substitution Task, Divided Attention Task, Rapid 
Information Processing Task, Repeated Acquisition Task, and an Immediate and Delayed Memory Task (see Foltin and 


Uploaded Protocol Summary Form 
 
Research Related Delay to Treatment 
Clinical Treatment Alternatives 
Risks/Discomforts/Inconveniences 
 
 
Evans, 1993) will be completed 6 times/day. The battery assesses subtle changes in mental acuity, learning, and working 
memory, which could impact the medications’ practical utility in the clinic. 
 
Self-Report Questionnaires: 
Drug Effects Questionnaire: 1 min Cannabis Rating Form (MRF): 2 min State Anxiety Inventory: 1 min 
Visual Analog Craving Scales (CAS): 3 min Beck Depression Inventory: 5 min 
 
Food Intake: A wide range of food items are available ad libitum. Participants scan each item with a bar code scanner 
before consumption, which tracks timing as well as caloric and macronutrient content. 
 
Additional Behavior: Social Behavior 
 
Physiological Measures: 
Qualitative Urinalysis: Collected daily; analyzed biweekly 
ActiwatchTM: Worn daily, measures activity 
ECG at study termination, heart rate and blood pressure daily 
 
Research involving participants who are in need of treatment invariably involves delay to care, and this delay is 
associated with risk. Scheduling of procedures must be carefully organized to minimize delay. Other delay must involve 
only that minimally necessary to accomplish the aims of the research while respecting subject well- being and safety. 
Describe the delay, by virtue of research participation in this study, before a participant can receive treatment of known 
efficacy or standard care routinely offered in the community. 
 
Research procedures will not result in a delay to treatment since participants are not seeking treatment for cannabis 
use. Nonetheless, all will be informed of cannabis treatment at STARS in case they change their minds in the future. 
 
Describe what other treatment or assessment options are available to subjects who do not participate in research. 
 
Participants are not seeking treatment. The alternative is to not participate in this study. 
 
"Risk" is a broad term used to convey the potential for harm, burden, and inconvenience related to research 
participation. Use this section to provide a comprehensive description of foreseeable physical, psychological, social, 
interpersonal, and economic risks introduced by the research. Include the source of the information. Consider both the 
probability and magnitude of harm and its impact. Describe the foreseeable harms associated with the research 
(untoward effects of a medication) and those related to delay to individualized treatment. Include data from the 
literature, and local data, if available, on risk rates and subject experiences with research procedures. Describe 
procedures in place to minimize risk. In general, please create a numbered list of risks/categories of risk, and in general 
put the list in the order of significance or level of risk, the most significant risks first followed by others. 
 
Cannabis: Possible side effects of smoked cannabis include: sedation, gait disturbance, tiredness, sadness, anxiety, 
concentration difficulties, increased heart rate, palpitations, dizziness, sleep disturbance, changes in food intake, 
restlessness, confusion, sleepiness, clumsiness, gastrointestinal upset, headache, nausea, dry mouth, pallor, flushing, 
sweating, and slurred speech. Side effects associated with cannabis withdrawal, e.g., sleep difficulty, irritability, upset 


Uploaded Protocol Summary Form 
 
 
 
stomach, restlessness, anxiety and loss of appetite may also occur. All participants are fully informed of the side effects 
that they might experience, and because all currently smoke cannabis, these effects should be familiar to them. 
 
Lorcaserin: Lorcaserin is well tolerated, with no evidence of the side effects commonly associated with 5HT2b or 5HT2a 
receptor agonists, e.g., abuse, hallucinations, cardiac valve disease (see Smith et al., 2010; Fidler et al., 2011; Shram et 
al., 2011). Transient and mild side effects include headache, dizziness, fatigue, nausea, dry mouth, constipation, cough, 
and back pain (Product label; Smith et al., 2010). Participants will be warned of rare but serious side effects include 
agitation, confusion, hallucinations, irregular heartbeat, depression, thoughts of suicide, and for men, an erection lasting 
longer than 4 hours. They will also be warned that they should use caution if they drink alcohol, drive a motor vehicle or 
operate heavy machinery until they know how the medication affects them (although they will be inpatient for all but 2 
of the 14 days they take the medication). Participants will not be taking any medications, but will be warned not to take 
any dietary supplements such as St. John's Wort, tryptophan and drugs that impair metabolism of serotonin, such as 
dextromethorphan since serotonin syndrome, a potentially life-threatening drug reaction, can occur when two drugs 
that affect the body’s level of serotonin are taken together. They will also be warned about the potential for heart valve 
problems and changes in white and red blood cells. 
 
Given that only healthy participants will be enrolled and will only receive an active dose of lorcaserin for 14 days, these 
rare side effects are even less likely. In clinical trials of 1-year duration: 2.4% of patients receiving lorcaserin and 2.0% of 
patients receiving placebo developed echocardiographic criteria for valvular regurgitation at one year. Decreases in 
white blood cell count were reported in 0.4% of patients treated with lorcaserin as compared to 0.2% of patients treated 
with placebo. Decreases in red blood cell count were reported by 1.3% of patients treated with lorcaserin as compared 
to 1.2% treated with placebo. The participants will be inpatient in a closely-monitored residential laboratory setting 
within the NY State Psychiatric Institute for 12 of the 14 days they are taking lorcaserin so we will monitor them closely 
throughout their participation. We will do an ECG at screening and at the end of the study, and assess vital signs each 
day. 
 
Inpatient Research Designs: There are also minor risks of isolation, boredom, and inactivity associated with living in the 
residential laboratory. In participants we have tested to date under similar conditions, such problems have been 
minimal. We describe at length possible difficulties of living in the residential lab before volunteers sign the study 
consent form. 
 
Phlebotomy: Participants will provide a blood sample during screening; they will be warned that blood drawing may 
cause slight discomfort at the site of needle entry and may result in a small bruise. 
 
Methods to Protect Confidentiality 
 
Describe the data management plan and the methods you will employ to protect subject privacy and the confidentiality 
of research data. The section should detail how information will be collected, recorded, coded, stored, transmitted, and 
as applicable, shared with other investigators so as to minimize risks related to breach of confidentiality. Confirm that 
identifiers are removed, to the extent possible, from research data, and explain if there are links between subject identity 
and research data, or if the data is anonymous. Also, indicate where the data is stored, who is responsible for its 
safekeeping, and who has access to subject identity and codes, if any, which cross-link research data and subject identity. 
Confirm that identifiable data is not collected, stored, or transmitted by mail, fax, on removable drives, laptops, or via the 
internet without proper protections, e.g. encryption. 
 
A Certificate of Confidentiality has been obtained for this study from the National Institute on Drug Abuse. Our records 
will be kept confidential and will only be accessible to study staff. Screening information, which may have the 
participant’s name, will be kept in a locked filing cabinet. Once a participant is enrolled into the study all further 
documents will be identified solely by initials and an assigned number. 


Uploaded Protocol Summary Form 
 
 
 
Describe only benefits to individual subjects that are likely to accrue during the study itself. Do not include subject 
compensation or treatment to be provided at the end of the study, as these do not figure into the IRB's risk benefit 
considerations. Do not describe diagnostic and evaluation components unless subjects receive clinical feedback. Do not 
describe the anticipated scientific benefits of the research. Some studies offer no direct benefit to subjects. 
There are few direct benefits to research volunteers in the proposed study. Prior to study acceptance, all volunteers will 
have a medical and psychiatric work-up. Thus, even if participants are not accepted into the study, they will benefit from 
these evaluations. We offer all participants the option of obtaining help to abstain from drug taking. Volunteers 
understand that they can obtain a referral for drug treatment at any stage of their research participation. We repeat our 
offer for treatment referral at discharge from the study. We will attempt to obtain a placement in a drug abuse clinic for 
those people who indicate a desire for help, and will inform all volunteers of our ongoing cannabis-treatment studies 
conducted within the Division of Substance Abuse. The major benefit of this research from our point of view is scientific. 
There is clearly a need for better treatment options for cannabis dependence. The model we are proposing to develop 
will allow us to better understand the effect of a potential treatment medication.. 
Direct Benefits to Subjects 


Uploaded Protocol Summary Form 
 
 
 
 
 
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References 


Uploaded Protocol Summary Form 
 
 
 
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